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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, BPH Subject signed informed consent prior to the performance of any study procedures Male with symptomatic BPH: IPSS symptom severity score ≥ 10 Peak urinary flow of < 12 ml/sec at flowmetry with minimum voided volume of at least 120 cc Prostate volume 25 ml to 80 ml (as assessed by TRUS) Subject that is able to complete the study protocol Normal Urinalysis and urine culture Previous prostate surgery Prostate cancer Urethral stricture Bladder stones An active urinary tract infection Obstructing median lobe demonstrated by IPP grade 3 (>1 cm) as assessed by TRUS Neurological conditions potentially affecting voiding function A post void residual (PVR) volume > 250 ml measured by ultrasound Previous diagnosis or treatment for Over Active Bladder Acute Urinary Retention
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Renal Replacement Therapy for Acute Kidney Injury in ICU All of the following must be fulfilled to be included in the observational study (first stage) Adults (>18 years) Hospitalized in a study ICU Evidence of acute kidney injury compatible with the diagnosis of acute tubular necrosis in a context of ischemic or toxic aggression and who receive (or received for the same episode) invasive mechanical ventilation and/or catecholamine infusion Acute kidney injury stage 3 of KDIGO classification defined by at least one of the following serum creatinine concentration of more than 4 mg/dl (354 µmol/liter) or greater than 3 times the baseline creatinine level, anuria (urine output of 100 ml/day or less) for more than 12 hours, oliguria (urine output below 0.3 ml/kg/h or below 500 ml/day) for more than 24 hours. To be randomized (randomization stage), supplemental must be fulfilled. These can appear either immediately after in the observational stage, or during the follow-up of the patient in the observational stage, in the absence of any non-inclusion (listed below) at the time of randomization Oliguria/anuria (urine output <0.3 ml/kg/h or <500 ml/day) for more than 72 hours or serum urea concentration comprised between 40 and 50 mmol/l Affiliation to a social security regime Severity mandating immediate RRT initiation (Table 1) Serum urea level > 50 mmol/l Severe chronic renal failure (defined by a creatinine clearance < 30 ml/min) Patients with already present for more than 24 hours (to avoid delayed inclusions) AKI caused by urinary tract obstruction or renal vessel obstruction or tumour lysis syndrome or thrombotic microangiopathy or acute glomerulopathy Poisoning by a dialyzable agent Child C liver cirrhosis Cardiac arrest without awakening Moribund state (patient likely to die within 24h) Patient having already received RRT for the current episode of AKI
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Cardiac Surgery Fluid Challenge Fluid Responsiveness Mechanical Ventilation acute circulatory failure (low blood pressure or urine output, tachycardia, or mottling) clinical signs of organ hypoperfusion (renal dysfunction or hyperlactatemia) a contraindication to elevation of tidal volume evidence of cardiac arrhythmia left ventricular ejection fraction less than 50% echocardiographic examination that showed the existence of severe tricuspid or mitral regurgitation or right heart dysfunction intracardiac shunt pulmonary hypertension severe chronic obstructive pulmonary disease a contraindication to the passive leg raising (PLR) test air leakage through chest drains abdominal compartment syndrome
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urinary Bladder, Neurogenic Males age ≥ 18 with clinical diagnosis of neurogenic lower urinary tract dysfunction (NLUTD) Must be clinically suitable and capable of safely managing bladder using an intermittent voiding strategy Must have stable urinary management history with clean intermittent catheterization: no significant changes in bladder management regimen within past 12 months OR: Must have urodynamic profile suitable for CIC, as assessed via urodynamics study within past 12 months (including bladder capacity > 200mL without uninhibited bladder contractions) Subject's lower urinary tract anatomy (lengths of proximal and distal urethral must fall within the ranges serviceable by the Connected Catheter device, as specified in the investigational device instructions for use For cases of NLUTD due to spinal cord injury, the subject must be in medically stable condition (i.e. post-spinal shock phase) Active symptomatic urinary tract infection, as defined in this protocol (subjects may receive the CoCath Device after UTI has been treated) Significant risk profile or recent history of urethral stricture (e.g. stricture within past 90 days) Significant risk profile or recent history of clinically significant autonomic dysreflexia (e.g. History of hospitalization due to AD within past 12 months) Significant intermittent urinary incontinence (between catheterizations) Uninhibited bladder contractions and/or vesico-ureteral reflux that is not reliably controlled with medication or alternate therapy (e.g. botox injections) Pre-existing urinary pathologies and/or morphological abnormalities of the lower urinary tract or bladder (assessed during in-depth medical screening, including cystoscopy, urine analysis, and blood labs) Urinary tract inflammation or neoplasm Urinary fistula Bladder diverticulum (outpouching) > 5cm in size Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months)
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, High-risk Surgical Patients 18 years of age or more, 2. Male or female, 3. High-Risk surgical patient, 4. Life expectancy expected to exceed 72 hours, 5. Willing to participate and signed informed consent, 6. Affiliation to the French social security system. Non 1. Pregnant or lactating woman, 2. History of recent urological surgery (bladder surgery, prostate surgery…), 3. Known stricture or "impossible insertion" last hospitalization, 4. Traumatic injury to the lower urinary tract, 5. History of radiotherapy of pelvic or genital area, 6. Genital malformation (Hypospadias…)
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 2.0-999.0, Neurogenic Bladder Due to Spina Bifida (Disorder) age ≥ 2 years diagnosis of spina bifida had self-IC or performed by a trained person ≥ 3 months using reused PVC catheter (1 per week) with clean technique able to read and understand informed consent other causes of neurogenic bladder symptomatic UTI at the time of initial evaluation inconsistent IC indwelling catheter allergy to PVC urethral pathology (ie stricture, false passage, hypospadias) rejection to participate in trial
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-90.0, Urinary Retention Acute Kidney Injury ICU dialysis patients who have their catheter removed per ICU medical team ICU patients without an indwelling urinary catheter and inability to void 6 hours post urinary catheter removal or 6 hours after admission Pregnant women Prisoners
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Bladder Neoplasm Prostate Neoplasm Pelvic Neoplasm Urologic Neoplasms Opioid Use Anesthesia, Local Pain, Postoperative Adult patients over 18 years Undergoing major urological surgery Consent to a rectus sheath blockade as part of their postoperative management Patients under 18 years Local or systemic infection Patients who refuse consent Opioid tolerance History of chronic pain Psychiatric illness Allergy to local anesthetic
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Benign Prostatic Hyperplasia (BPH) Male patient scheduled to undergo prostatectomy using holmium laser Urethral stricture, large bladder diverticulum, bladder neck contracture
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-80.0, Nasogastric Tube Decompression Pancreatic Surgery Patients with age between 18 years Patients underwent any kind of pancreatic surgeries, including but not limited to PD, distal pancreatectomy, central pancreatectomy, pancreatic enucleation, etc Patients accepted the trial and could completed a written consent Combined with digestive tract obstruction before the surgery History of upper abdominal surgery Serious heart, brain, lung, metabolic diseases history Pregnant women Unwillingness or inability to consent for the study
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 1.0-18.0, Urethral Injury Male children less than 18 years presenting with pelvic fracture urethral injury Associated bladder neck injury Associated rectal injury Late presentation >2weeks since trauma History of previous urethral intervention
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urinary Incontinence Women> 18 years, diagnosed with hyperactive bladder syndrome for at least 6 months of evolution and who have taken Beta 3 agonists Patients who can contribute biased information: have previously consumed and abandoned anticholinergic drugs due to lack of efficacy or side effects; Suffering from hyperactive bladder of neurogenic origin (multiple sclerosis, Parkinson's, spinal cord injury); Present cystocele or any pelvic organ prolapse> 2 according to Pelvic Organ Prolapse-Q classification Patients who may become worse with the interventions envisaged in the study: being a implantable automatic defibrillators; With cutaneous alterations in lower extremities that prevent the placement of electrodes on the surface; Women who are pregnant or who may be pregnant during the duration of the clinical trial (prior and at each evaluation visit urine Bhcg will be requested to rule out pregnancy) or patients who are not able to manage transcutaneous electrical neurostimulation on an outpatient basis ) Or patients in whom Solifenacin is contraindicated: urinary retention, severe gastrointestinal disorders (including toxic megacolon), myasthenia gravis, or narrow-angle glaucoma, and in patients at risk of these conditions as hypersensitive at first Active or to any of the excipients, undergoing hemodialysis, with moderate hepatic insufficiency or severe renal insufficiency or in simultaneous treatment with a potent inhibitor of CYP3A4, eg ketoconazole
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urethral Stricture Male subjects ≥ 18 years' old 2. Visual confirmation of stricture via cystoscopy or urethrogram 3. Single, tandem or diffuse anterior urethral stricture(s), less than or equal to 3.0 cm total length measured by retrograde urethrogram. (Stricture length is defined as the distance between the most distal edge of the stricture to the most proximal edge of the stricture). 4. Two or more prior dilation treatments of the same stricture, including DVIU (Direct Vision Internal Urethrotomy), but no prior urethroplasty. 5. Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent urinary tract infections (UTI's). 6. International Prostrate Symptoms Score (IPSS) score of 11 or higher (assumed to be "35" if suprapubic catheter is present) 7. Lumen diameter ≤ 12F by urethrogram 8. Qmax <15 ml/sec (assumed to be "0" if suprapubic catheter is present) 9. Guidewire must be able to cross the lesion Subjects with diffuse stricture length, greater than 3.0 cm in total length. (Stricture length is defined as the distance between the most distal edge of the stricture to the most proximal edge of the stricture). 2. Subjects with a history of hypersensitivity reactions to TAXOL, on medication that may have negative interaction with paclitaxel, with solid tumors who have a baseline neutrophil counts of <1500 cells/mm3 or subjects with AIDS-related Kaposi's sarcoma with baseline neutrophile counts of <1000 cells/mm3. 3. Subjects who had an indwelling suprapubic catheter longer than three (3) months total prior to enrollment. 4. Previous urethroplasty within the anterior urethra 5. Stricture dilated or incised within the last six (6) weeks (urethral catheterization is not considered dilation) 6. Presence of local adverse factors, including abnormal prostate making catheterization difficult, urethral false passage or fistula. 7. Presence of signs of obstructive voiding symptoms not directly attributable to the stricture at the discretion of the physician 8. Diagnosis of untreated and unresolved BPH or BNC 9. Untreated stress urinary incontinence (SUI). 10. History of diagnosed radiation cystitis. 11. Diagnosis of carcinoma of the urethra, bladder or prostate within the last two (2) years 12. Active kidney, bladder, urethral or ureteral stone passage in the last six (6) weeks or concern of stone passage in the next 6 weeks at the discretion of the investigator. 13. Diagnosis of chronic renal failure and treatment with hemodialysis 14. New diagnosis of OAB (overactive bladder) within the last six (6) months 15. Use of alpha blockers, beta blockers, OAB (Overactive Bladder) medication, anticonvulsants (drugs that prevent or reduce the severity and frequency of seizures), and antispasmodics where the dose is not stable. (Stable dose is defined as having the same medication and dose in the last six months.) 16. Dependence on Botox (onabotulinumtoxinA) in urinary system 17. Presence of an artificial urinary sphincter, slings, or stent(s) in the urethra or prostate 18. Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function 19. Diagnosed with Lichen Sclerosus, or stricture due to balanitis xerotica obliterans (BXO) 20. Previous hypospadias repair 21. History of cancer in non-genitourinary system which is not considered in complete remission (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered in complete remission if there has been no evidence of cancer within two (2) years of enrollment 22. Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affect the ability to complete the study quality of life questionnaires 23. Unwilling to use protected sex for thirty (30) days' post treatment 24. Unwilling to abstain or use protected sex for ninety (90) days post treatment if sexual partner is of child bearing potential. 25. Inability to provide Informed Consent Form (ICF) and/or comply with all the required follow-up requirements 26. Participation in other pre-market studies or treatment with an investigational drug or device. Long term follow up or post market study of an approved device is allowed. 27. Current active infection in the urinary system 28. Current uncontrolled diabetes (hemoglobin A1c > 8.0%) or evidence of poor wound healing due to diabetes 29. Diagnosed or suspected primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function, sphincter function or poor detrusor muscle function. 30. Visible hematuria in subject's urine sample without known contributing factor 31. Invisible hematuria (or significant microscopic hematuria, i.e. hematuria of ≥ 3 RBC's/HPF) that may be caused by a clinically significant disease unless it is attributed to the urethral stricture disease or other causes which are benign and not requiring treatment
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-999.0, Prostate Cancer Clinical stage T1c/T2 PSA ≤ 20ng/mL Biopsy GS ≤ 6 with any number of cores positive, or Biopsy GS 3+4 disease with ≤3 positive cores or ≤ 33% positive cores The patient must be ≥ 50 years of age The patient must have a life expectancy of > 10 years Patient must be able to give consent in English or Spanish Clinical stage T3a or above PSA > 20ng/mL Biopsy GS 4+3 or > 8 Known metastatic prostate cancer Positive biopsy for prostate cancer > 3 months ago Treatment decision has already been made Insufficient tumor in prostate biopsy tissue to perform the assay Treatment with androgen deprivation therapy (ADT) prior to prostate biopsy Diagnosis made by transurethral resection of prostate (TURP) shavings Any psychiatric or psychological conditions
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-90.0, Hysterectomy Women age 18-90 Undergoing hysterectomy with or without concomitant procedures Known history of urinary tract anomaly (i.e. urethral diverticulum, ureteral duplication, ectopic ureter) ≥3 UTIs in past 6 months Immunosuppressed patients Premeditated urologic procedure during hysterectomy surgery
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-0.077, Bronchopulmonary Dysplasia Birth weight < 1,250 grams Gestational age < 32 weeks Need for assisted, invasive mechanical ventilation with at least the following settings: ventilation rate > 15 breaths per min, fractional oxygen concentration of inspired gas (FiO2) > 30% but < 60%) Postnatal age 10-21 days Stable ventilatory requirements over the 48-72 hours prior to enrollment Actual or suspected sepsis Congenital cardiorespiratory malformation Patent ductus arteriosus Presence of necrotizing enterocolitis Presence of gastrointestinal hemorrhage or perforation Treatment with systemic dexamethasone
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia All patients treated for BPH / LUTS / prostatic obstruction at the urological department of KSSG Patient age ≥ 18 years Informed consent provided -Cognitive impairment not allowing Informed Consent or adequate data assessment
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 1.0-999.0, Trauma;Pelvis The are: All patients with pelvic fracture and urethral distraction injury (PFUDDI) except patients with any of the The are: 1. Bladder neck injury 2. Rectal injury 3. Urethrorectal injury 4. Spinal cord injury 5. Associated anterior urethral strictures
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-99.0, Dysuria Adult patients, age 18 and older scheduled to undergo endourologic procedure to ureteroscopy, rigid diagnostic cystoscopy, bladder biopsy, laser lithotripsy, cystolithalopaxy, and transurethral resection of bladder tumor in the operating room under general anesthesia. - active urinary tract infection, current dysuria symptoms, pregnant females, urethral stricture disease, indwelling foley catheter, and history of pelvic radiation -
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 16.0-999.0, Urothelial Carcinoma Any patient referred with haematuria (visible and non-visible) undergoing cystoscopy Any patient referred without haematuria undergoing cystoscopy for the purpose of ruling out urothelial cancer suspected due to other symptoms (e.g. lower urinary tract symptoms, recurrent urinary tract symptoms, dysuria) Patients with a previous or known diagnosis of primary upper or lower urinary tract urothelial cancers (renal, ureteric, bladder, prostate, urethral and penile cancers) Patients with suspected recurrence of upper or lower urinary tract primary urothelial cancer (renal, ureteric, bladder, prostate, urethra and penile cancers) Patients undergoing flexible cystoscopy for a reason unrelated to ruling out urinary tract urothelial cancer
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urethral Stricture Surgery Urologic Diseases Voluntary signed written informed consent (according to the rules of Good Clinical Practice and national regulations) Male Age >= 18 years Fit for operation, based on the surgeon's expert opinion Isolated short (=< 3cm) bulbar urethral stricture confirmed by preoperative retrograde urethrography (RUG), voiding cysto-urethrography (VCUG), cystoscopy, ultrasonography or a combination of investigations Unique urethral stricture Urethral stricture =< 3 cm Urethral stricture at the bulbar segment Patient declares that it will be possible for him to attend the follow-up consultation Absence of signed written informed consent Age <18 years Female patients Transgender patients Patients unfit for operation Concomitant urethral strictures at other urethral locations (penile urethra, membranous urethra, prostatic urethra, bladder neck) Urethral strictures exceeding 3 cm A unique urethral stricture at other urethral locations (penile urethra, membranous urethra, prostatic urethra, bladder neck) Lichen Sclerosus related strictures Strictures after failed hypospadias repair
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urinary Incontinence Radical Prostatectomy Pelvic Floor Having undergone a radical prostatectomy surgical procedure Presenting involuntary urine losses after radical prostatectomy intervention. (IU grade I, II or III) Do not exceed the year since the surgical intervention Accept to participate in the study and grant signed informed consent Follow a pharmacological treatment for the UI Presenting anatomical malformations of the pelvic floor musculature Carry pacemaker Present anal fistulas suffer from serious psychic disorders Presenting lower urinary tract infections
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Lung Cancer Metastatic Locally Advanced Malignant Neoplasm Non Hodgkin Lymphoma Urologic Neoplasms Age > 18 years Diagnosis of locally advanced or metastatic solid tumor or lymphoma treated with Immune check blockade Signed informed consent Affiliated to(or beneficiary of) the French Social Security Pregnant or breastfeeding woman or woman who does not apply effective contraception Emergency Vulnerable person or unable to provide informed consent Emergency Person unable to comply with required study follow up Contraindication to the study procedure
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Lower Urinary Tract Symptoms Male aged 18 years old or over Referred for video urodynamics within our department Predominant voiding LUTS as assessed by IPSS at screening. [The total IPSS score is out of 35, with up to 15 points for storage symptoms and 20 for voiding symptoms. If voiding symptoms as a percentage of total score is higher than storage symptoms they will be included in the study] Capacity to understand study procedures and give informed consent At least 2 voided volumes on frequency volume chart (FVC) of 250 mL Female patients Long term catheterisation Predominant storage LUTS on IPSS at screening Fewer than 2 voids on FVC > 250 mL Known pre-existing neurological cause for symptoms Active urinary tract infection (UTI)
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urinary Incontinence Male 18 years of age or older 2. At least 6 months post radical prostatectomy for localized prostate cancer 3. Cystoscopic evaluation of the lower urinary tract within 12 months of screening 4. Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status 5. Evidence of moderate to severe urinary incontinence as assessed by the investigator, requiring protective garments or pads 6. Post-surgical Prostate Specific Antigen (PSA) <0.04 Inability to insert the Comfort Plug™ into his own urethra and remove it 2. History of significant incontinence prior to radical prostatectomy 3. Evidence of incomplete bladder emptying post radical prostatectomy 4. Recurrent , refractory bacteruria 5. Urethral stricture disease. 6. History of meatal stenosis or phimosis 7. History of any other malignancy except basal cell skin cancer 8. Planned radiotherapy for post prostatectomy residual disease within the next 90 days 9. Evidence of neurogenic bladder dysfunction 10. Multiple sclerosis or previous spinal cord trauma/pathology resulting in any neurologic deficit that, in the opinion of the investigator, might compromise the outcome 11. Ongoing constipation 12. Use of anticoagulant or antiplatelet medications excluding low-dose Acetylsalicylic acid (ASA) 13. Hemophilia 14. Any cardiac condition that requires the use of pre-procedure antibiotic prophylaxis such as a mechanical valve 15. Currently receiving successful medical treatment for incontinence. 16. The usage of male urethral slings 17. Planning to travel by airplane during the course of the study
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-999.0, BPH With Urinary Obstruction BPH BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms Male subjects ≥ 50 years of age who have symptomatic BPH. 2. International Prostate Symptom Score (IPSS) score ≥ 13. 3. Peak urinary flow rate (Qmax): ≥ 5ml/sec to ≤ 12 ml/sec with minimum voided volume of ≥ 125 ml. 4. Post-void residual (PVR) ≤300 ml. 5. Prostate volume >80 cm3 to ≤150 cm3 Urology: 1. Any prior invasive prostate intervention (e.g., "Radiofrequency" thermotherapy, balloon, microwave thermotherapy, "Prostatic Urethral Lift", "Transurethral Resection", or laser) or other surgical interventions of the prostate. 2. Undergone a prostate biopsy within 60 days prior to the scheduled treatment date or has an imminent need for surgery. 3. Verified acute bacterial prostatitis within last 12 months documented by culture. 4. Active or history of epididymitis within the past 3 months. 5. Urethral strictures, bladder neck contracture, unusual anatomy or muscle spasms that would prevent the introduction and use of the Rezūm device. 6. Diagnosed bladder, urethral or ureteral stones or active stone passage in the past 6 months, provided that stones that are known to be in the kidney and have been stable for a period exceeding 3 months are permissible. 7. Subject interested in maintaining fertility. 8. Use of the following medications where the dose is not stable (stable dose defined as the same medication and dose in the last three months): 1. Beta-blockers; 2. Anticonvulsants; 3. Antispasmodics; 4. Antihistamines; 5. Alpha blockers for BPH and anticholinergics or cholinergics; 6. Type II, 5-alpha reductase inhibitor (e.g., finasteride (Proscar, Propecia)); 7. Dual 5-alpha reductase inhibitor (e.g., dutasteride (Avodart)); 8. Estrogen, drug-producing androgen suppression, or anabolic steroids; 9. PD5 Inhibitors (e.g., Viagra, Levitra or Cialis) 9. Subjects who have had an incidence of spontaneous urinary retention either treated with indwelling transurethral catheter or suprapubic catheter 6 months prior to baseline. A provoked episode now resolved is still admissible 10. Evidence of atonic neurogenic bladder evaluated by a baseline urodynamic assessment. 11. Visible hematuria with subject urine sample without a known contributing factor. 12. Presence of a penile implant or stent(s) in the urethra or prostate 13. Active urinary tract infection by culture within 7 days of treatment or two documented independent urinary tract infections of any type in the past 6 months. Gastroenterology: 14. Previous pelvic irradiation or radical pelvic surgery. 15. Previous rectal surgery (other than hemorrhoidectomy) or known history of rectal disease. Nephrology: 16. Compromised renal function defined as serum creatinine > 2.0 mg/dl. 17. Hydronephrosis (Grade 2 or higher). Oncology: 18. Prostate cancer testing: If PSA is > 2.5 ng/ml and ≤ 10 ng/ml with free PSA <25%, prostate cancer for the subject must be/had been ruled out through a negative biopsy prior to enrollment Males 50-59 years PSA is >2.5 ng/ml and ≤10 ng/ml with free PSA <25% Males 60+ years PSA is >4 ng/ml and ≤10 ng/ml, with free PSA <25% 19. History of confirmed malignancy or cancer of the prostate or bladder; however, high grade prostatic intraepithelial "PIN" is acceptable. 20. History of cancer in non-genitourinary system that is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years of enrollment. Cardiology: 21. History of clinically significant congestive heart failure (i.e., NYHA Class III and IV). 22. Cardiac arrhythmias that are not controlled by medication and/or medical device. 23. An episode of unstable angina pectoris, a myocardial infarction, transient ischemic attack, or a cerebrovascular accident within the past six months. Pulmonology: 24. History of significant respiratory disease where hospitalization for the disease is required. Hematology: 25. Diagnosed or suspected bleeding disorder, or coagulopathies. 26. Use of antiplatelet or anticoagulant medication except low dose aspirin (<100mg/day) within 10 days prior to treatment. Endocrinology: 27. History of diabetes not controlled by a stable dose of medication over the past three months, provided that patients with a hemoglobin A1c <8.0% are allowed. Immunology: 28. History of immunosuppressive conditions (e.g., AIDS, post-transplant). Neurology: 29. Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affect the ability to complete the study quality of life questionnaires. 30. Diagnosed or suspected primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function, sphincter function or poor detrusor muscle function (< 25% of accepted and established nomograms). General: 31. Currently enrolled in any other pre-approval investigational study in the US (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.). 32. Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study. 33. Inability to provide a legally effective "Informed Consent Form" and/or comply with all the required follow-up requirements
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urethral Catheter Removal After Urologic Procedure Patients undergoing trial of void after placement of indwelling urethral catheter after urologic procedure Patient incontinent at baseline Patient has chronic indwelling urinary catheter or uses clean intermittent catheterization at home Patient has documented neurogenic bladder No trained person to administer the instillation or perform consent Patient refusal to participate Patient unable to give informed consent Patient is a prisoner Patient is pregnant Patient unable to participate in notifying nursing of voids Nursing is unable to measure post void residual with bladder scan machine secondary to body habitus or other anatomical abnormality
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 65.0-999.0, Urinary Retention Males ≥65 years old Planned surgical procedure of a video assisted thoracoscopic surgery (wedge resection, lobectomy, pleural biopsy, or pleurodesis) Surgery scheduled more than 7 days from the time of consent Using Flomax already Allergy to Flomax or sulfa drugs Current use of alpha blockers or alpha agonists Resting systolic blood pressure <100 Orthostatic hypotension of >20mm Hg (millimeters of mercury) Systolic and/or 10mm Hg diastolic pressure from sitting to standing (after 2 minutes of standing) as measured at the time of consent Known diagnosis of congestive heart failure and valvular heart disease History of prostate surgery (prostatectomy, trans-urethral resection)
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Acute Kidney Injury Uremia Fluid Overload Dialysis; Complications Critical Illness *Critically ill patients admitted to intensive care units in Stockholm at: Karolinska University Hospital (Solna and Huddinge) and at Södersjukhuset. *Patients over 18 years of age Patients <18 years Patients with DNAR (do not attempt resuscitation)-orders Patients dying within 12 hours of commencing renal replacement therapy
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 20.0-80.0, Overactive Bladder Syndrome Male patients with BPH and undergo TURP or TUIP. 2. Patients void smoothly after catheter removal. 3. No active urinary tract infection. 4. No gross hematuria or blood clot obstruction. 5. Patient or his care giver can complete voiding diary and report symptoms Patients have overt neurological diseases such as cerebrovascular disease, senile dementia or spinal cord injury. 2. Patients have severe medical disease and completely immobile. 3. Patients have PVR larger than 150ml. 4. Patients do not have OAB after TURP
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 40.0-999.0, Prostatic Hyperplasia, Benign Male ≥ 40 years of age Peak urinary flow rate (Qmax): ≥ 5 mL/sec to ≤ 15 mL/sec, with a minimum voided volume of ≥ 125 mL, measured with uroflowmetry or urodynamic investigation Post-void residual (PVR): ≤ 250 mL Prostate volume: ≥ 30 and ≤ 120 cc, measured by transrectal ultrasound Urodynamic investigation proven bladder outlet obstruction Signed informed consent Previous invasive prostate intervention (TURP, laser, ablation, etc.) History of prostate or bladder cancer Indwelling Foley catheter or clean intermittent catheterization (CIC) PSA of ≥ 3.0 ng/mL without negative biopsies Inability or unwillingness to tolerate temporary discontinuation of anticoagulation or anti-platelet therapy Other conditions / status Active urinary tract infection / prostatitis Macroscopic haematuria without a known contributing factor Poor detrusor muscle function or other neurological disorder that would impact bladder function (eg, multiple sclerosis, Parkinson's disease, spinal cord injuries, (diabetic) polyneuropathy) Concurrent malignancy except basal skin cancer
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Bladder Cancer Patient is undergoing investigative cystoscopies for the monitoring of recurrence of urinary tract UC at intervals prescribed by the clinical practitioner 2. Patients on an "all-comers" basis 3. Positive diagnosis for primary or recurrent bladder tumour within the past 5 years 4. Able provide a voided urine sample of the required minimum volume 5. Able to give written consent 6. Able and willing to comply with study requirements 7. Aged 18 years or older Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection, 2. Patients who had exposure to intravesical BCG, had completed induction BCG but without a subsequent clear cystoscopy 3. Recent history of glomerulonephritis, nephrosis or other renal inflammatory disorders, 4. Recent history of pyelonephritis 5. Total cystectomy of the bladder, neo bladders and illeal conduits 6. Previous muscle invasive bladder tumour (pT2 or greater)
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Urinary Tract Disease Willing and able to provide written informed consent to participate in the study 2. Willing and able to comply with the study procedures 3. Diagnosed as urinary disease and indicated for flexible ureteroscope procedure 4. For stone cases, the diameter of stones is less than or equal to 2cm in order to avoid staged procedures Surgeries are contraindicated 2. Flexible ureterocope procedure is contraindicated 3. Based on doctor's evaluation, the patient's medical condition doesn't fit for this study 4. For stone cases, the diameter of stones is greater than 2cm 5. Women of childbearing potential who are or might be pregnant at the time of this study
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urothelial Carcinoma patients > 18 years patients reoperative predictive factors for final ureteral section invasion after radical cystectomy patients < 18 years
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Bladder Cancer newly diagnosed or followed as recurrent intermediate-risk non muscle invasive non muscle invasive bladder cancer according to the of European Association of Urology newly diagnosed or followed as recurrent high-risk non muscle invasive non muscle invasive bladder cancer according to the of European Association of Urology pathology of urothelial carcinoma Low bladder capacity (<150ml) increased post voiding residual urine (>150ml) untreatable or uncontrollable urinary tract infection history of urethral stricture presence of bladder diverticula larger than 1 cm pathology other than urothelial carcinoma WHO (World Health Organization) performance status > 2 upper urinary tract urothelial carcinoma diagnosis
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-65.0, Complications; Urethral Catheter Ureteral Catheterization Ureteroscopy Lower Urinary Tract Symptoms Flank Pain adult patients Patients with indications for semirigid or flexible ureteroscopy and DJ stent placement for unilateral ureteral and/or kidney stones according to European Association of Urology Urolithiasis Guidelines none
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Intravascular-catheter Colonization Catheter Failure Adult (age ≥ 18 years) patients Having clinical indication for placement of a single PVC for at least 48 hours (no minimum port access during the study duration) Willing and able to provide informed consent Known allergies to CHG, PVI, isopropanol or ethanol Participation to another clinical trial aimed at reducing PVC complications Suspicion of bloodstream infection at catheter insertion Skin injury a catheter insertion site increasing the risk of catheter infection PVC inserted extremely urgently, making it impossible to comply with the protocol Intravascular catheter in place within the last 2 days, or within the last 2 weeks and with local signs of catheter complication Difficult catheter insertion suspected (obesity, known IV drug users, non-visible venous network after placement of a tourniquet...) Patients already enrolled in this study Terminal or moribund patient not expected to live more than one week Patients not benefiting from a Social Security scheme or not benefiting from it through a third party
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Neurogenic Bladder Urinary Tract Infections >18 years of age 2. Spinal cord injury (>1 year), multiple sclerosis (>1 year), spina bifida, parkinsons (>1 year) 3. Indwelling catheter (urethral or suprapubic) for >3 months, and used as primary bladder management mechanism 4. >1 urinary tract infection in the last 12 months Intravesical botox in the last 6 months 2. Chronic antibiotic suppressive therapy 3. Active symptomatic UTI on day of randomization 4. Unable to understand written and spoken English 5. Prior/current utilization of the Uroshield device
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Bladder Infections and Inflammations Men or Women older than age 18 Indwelling Foley urinary catheter for at least 30 days prior to entry with anticipation for continued indwelling urinary catheterization for at least 30 days after entry into the study Inability to provide informed consent Unwilling or medically inappropriate for cystoscopy
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 51.0-999.0, Benign Prostatic Hyperplasia (BPH) Prostate Cancer International Prostate Symptom Score ≥ 12 Peak flow rate ≤ 12 ml/sec with at least 125 ml voided urine Prostate volume ≤ 80 cc as measured either by trans-rectal ultrasound (US) or Magnetic Resonance Imaging (MRI) Obstructive median lobe of the prostate Active urinary tract infection Neurogenic non-obstructive voiding dysfunction Obstructive symptoms secondary to prostate cancer (via cystoscopy) Patients with prior Transurethral resection of the prostate (TURP) Patients with prior history of urethral stricture
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-95.0, Small Renal Mass Kidney Tumor Ages 18 Have a small renal mass ≤7 cm on cross-sectional radiologic study evaluated at the University of North Carolina (UNC) Urology or the UNC Cancer Hospital Has voluntarily provided signed informed consent to participate and HIPAA authorization for release of personal health information Willing and able to complete patient-reported outcome questionnaires Willing to have extra cores taken for research during standard of care biopsy procedure Willing to allow surgical specimens to be used for research Willing to undergo a blood draw to evaluate for circulating tumor DNA Has staging information indicating locally advanced or metastatic disease Presence of transplant kidney Unwilling or unable to complete informed consent
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Alcoholic Hepatitis Sepsis Alcoholic Hepatitis diagnosed by one of the following methods: 1. liver biopsy 2. clinical diagnosis based on history of alcohol use, presence of jaundice (yellowing of skin), blood tests indicating liver injury, and absence of other causes of liver injury (autoimmune disease, viral hepatitis, drug toxicity) 2. Suspected or proven infection 3. Presence of systemic inflammatory response to infection (fever, hypothermia (low temperature), tachycardia (fast heart rate), leukocytosis (high white blood cell count), leukopenia (low white blood cell count), high respiratory (breathing) rate, or need for mechanical ventilation (a machine to assist in breathing). 4. Presence of organ failure due to the body's response to infection indicated by any of the following: 1. Hypotension (low blood pressure) or need for medications to raise blood pressure 2. Arterial hypoxemia (low blood oxygen) or need for high flow of oxygen 3. High lactate level (blood test indicating active response to infection) 4. Low urine output despite administration of intravenous fluids 5. Low platelet count (blood test) 6. Coagulopathy (decreased blood clotting ability based on a blood test) 7. High bilirubin (blood test) 8. Mental status changes (confusion or delirium) 5. Absence of drugs present on urine or blood tests that indicate the possibility of liver damage or mental status changes from other causes Allergy to Vitamin C 2. Unable to provide consent 3. Age less than 18 years 4. No intravenous access (IV line) in a patient needing glucose (blood sugar) checks more than twice daily 5. Presence of diabetic ketoacidosis (a serious complication of diabetes) 6. Inability of patient, legally authorized representative and/or physician to commit to full medical support 7. Pregnancy or breast feeding 8. Life expectancy less than 24 hours 9. Active or history of kidney stone 10. History of chronic kidney disease 11. History of glucose-6-phosphate deficiency (a low blood protein that can cause red blood cells to break down) 12. Active cancer (except non-melanoma skin cancer) 13. Uncontrolled gastrointestinal bleeding 14. Other causes of liver injury such as viruses, autoimmune disease, drug toxicity 15. History of severe liver cirrhosis complications including variceal bleeding within the last 3 months, large ascites (fluid accumulation in the abdomen) or hepatocellular carcinoma (liver cancer) 16. History of organ transplantation 17. Initial AST or ALT (blood test indicating a liver problem) 18. Presence of acetaminophen or other drugs on urine or blood toxicology test 19. Non-English speaking 20. Prisoner or other ward of the state
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Benign Prostatic Hyperplasia Patients who have been diagnosed with benign prostatic hyperplasia by a urologist Have been treated with conventional first-line western medicine for more than three months Patients with moderate to severe benign prostatic hyperplasia (IPSS score >12 points) Participate voluntarily in the study At the same time, use other Chinese herbal medicines or alternative medicine (including drugs and acupuncture) for more than one month Syphilis, gonorrhea and other sexually transmitted diseases or urinary tract infections Urinary tract stones, prostate cancer, bladder cancer or acute and chronic renal failure Congenital abnormalities such as bladder neck fibrosis, interstitial cystitis or urethral stricture A history of genital trauma or surgery affecting the muscle or nervous system Patients with upper urinary tract obstruction, renal edema, etc. affecting renal function Unable to sign a consent form or unable to communicate with researchers
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 22.0-999.0, Rhytides Wrinkle Healthy, male or female subjects over 21 years of age who are seeking treatment and reduction of their facial wrinkles. 2. Able to read, understand and voluntarily provide written Informed Consent. 3. Able and willing to comply with the treatment/follow-up schedule and requirements. 4. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline Implantable defibrillators, cardiac pacemakers, and other metal implants 2. Subjects with any implantable metal device in the treatment area 3. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant). 4. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance. 5. Current or history of any kind of cancer, or pre-malignant moles. 6. Severe concurrent conditions, such as cardiac disorders. 7. Pregnancy or intending to become pregnant during the study and nursing. 8. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications. 9. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only after a prophylactic regime has been followed for 2 weeks or longer prior to enrollment, or according to Investigator's discretion. 10. Poorly controlled endocrine disorders, such as diabetes. 11. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash. 12. History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin. 13. History of bleeding coagulopathies, or use of anticoagulants (excluding daily aspirin). 14. Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated. 15. Use of isotretinoin (Accutane®) or other systemic retinoids within six months or topical retinoids within three months prior to treatment; or as per physician's discretion. 16. Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen-containing agents) one week before and after each treatment session. 17. Any surgical procedure in the treatment area within the last six months or before complete healing. 18. Treating over tattoo or permanent makeup. 19. Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks. 20. As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Lower Urinary Tract Symptoms patients with lower urinary tract symptoms patients with Suprapubic catheter History of radical prostatectomy or cystoprostatectomy Clinical evidence of urethral stricture, prostatitis Patients with bacterial growth on urine culture
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-80.0, Catheter Thrombosis Catheter-Related Infections Central Venous Catheter Related Bloodstream Infection Central Venous Catheter Thrombosis Age > 18 years old and <80 years old Central venous catheter is required to be placed through the internal jugular vein, subclavian vein or femoral vein Catheter placement is estimated to be ≥ 72 hours The central venous catheter has been placed before entering the department There is obvious trauma or infection at the site of implantation There is already a blood vessel thrombus in the site before implantation Recently, deep vein thrombosis or catheter-related thrombosis has occurred
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urinary Retention Neurogenic Bladder Urologic Diseases Males age ≥ 18 with clinical diagnosis of significant urinary retention 2. Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling strategy Must have stable urinary management history as determined by the Investigator OR: Must have urodynamic profile suitable for the Gen 2 Connected Catheter (including bladder capacity > 200mL without uninhibited bladder contractions) 3. Subject's lower urinary tract anatomy must fall within the ranges serviceable by the Gen 2 Connected Catheter device, as specified in the Investigational Device Instructions for use (IFU) Active symptomatic urinary tract infection (UTI), as defined in this protocol (subjects may receive the device after UTI has been treated) 2. Significant risk profile or recent history of urethral stricture (e.g. stricture within past 90 days) 3. Significant risk profile or recent history of clinically significant (uncontrolled) autonomic dysreflexia (AD) 4. Significant intermittent urinary incontinence (between catheterizations) 5. Uninhibited bladder contractions and/or Vesicoureteral reflux that is not reliably controlled with medication or alternate therapy (e.g. Botox injections) 6. Pre-existing urinary pathologies and/or morphological abnormalities of the lower urinary tract or bladder (assessed during in-depth medical screening, including cystoscopy and urine analysis) 1. Urinary tract inflammation or neoplasm 2. Urinary fistula 3. Bladder diverticulum (outpouching) > 5cm in size 4. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months) 5. Impaired kidney function or renal failure 6. Active gross hematuria 7. Active urethritis 8. Bladder stones 7. Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted drug pump) or external device 8. Any unsuitable comorbidities as determined by the investigator or complications related to use of certain medications 9. Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the Connected Catheter System 10. Catheter Assessment Tool screening yields unacceptable results
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 40.0-90.0, Benign Prostatic Hyperplasia (BPH) moderate-to-severe lower urinary tract symptoms (IPSS ≥ 12) poor efficacy or tolerance to medical therapy for BPH transrectal ultrasound prostate volume between 30 and 120 ml ability to express written informed consent previous surgical treatments for BPH indwelling bladder catheter or clean intermittent catheterization bladder stones severe detrusor hypocontractility (BCI <50) or detrusorial acontractility urethral strictures neurological bladder not replaceable anticoagulant or antiplatelet drugs for severe cardiological comorbidity bladder cancer diagnosis or clinical suspicion of prostatic cancer
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urethral Stricture Urethral Stricture, Anterior Lower Urinary Tract Symptoms Anterior Urethral Stricture Male subjects ≥ 18 years old 2. Visual confirmation of stricture via cystoscopy or retrograde urethrogram 3. Single lesion bulbar urethral stricture, less than or equal to 3.0 cm 4. Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent urinary tract infections (UTIs). 5. IPSS score of 13 or higher 6. Lumen diameter <12F by urethrogram 7. Able to complete validated questionnaire independently 8. Qmax <15 ml/sec 9. Guidewire must be able to cross the lesion Strictures greater than 3.0 cm long 2. Subjects with greater than 1 stricture. 3. Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel 4. Previous urethroplasty within the anterior urethra 5. Stricture due to bacterial urethritis 6. Stricture due to untreated gonorrhea 7. Stricture due to Lichen Sclerosus, or balanitis xerotica obliterans (BXO) 8. Stricture dilated or incised within the last 3 months (apart from subjects on self-catheterization) 9. Presence of local adverse factors (e.g. abnormal prostate, urethral false passage or fistula) making catheterization difficult 10. Presence of signs of obstructive voiding symptoms not directly attributable to the stricture at the discretion of the physician 11. Diagnosis of untreated and unresolved severe BPH or bladder neck contracture (BNC), at the discretion of the physician 12. Prior diagnosis of overactive bladder (OAB) 13. Diagnosis of severe stress urinary incontinence (SUI), at the discretion of the physician 14. Previous radical prostatectomy that resulted in either unresolved bladder neck contracture (BNC) and/or unresolved incontinence 15. Previous pelvic radiation 16. Diagnosis of kidney, bladder, urethral or ureteral stones in the last 6 weeks or active stone passage in the past 6 weeks 17. Diagnosed with chronic renal failure, at the discretion of the physician 18. A dependence on Botox (onabotulinumtoxinA) in the urinary system 19. Presence of a penile implant, artificial urinary sphincter, or stent(s) in the urethra or prostate 20. Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function 21. Previous hypospadias repair 22. Diagnosis within the last 5 years of carcinoma of the bladder or prostate or suspicion of prostate cancer (e.g. abnormal DRE or high PSA) at the discretion of the physician 23. Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affect the ability to complete the study quality of life questionnaires 24. Unwilling to use protected sex for ≥30 days post treatment 25. Unwilling to abstain or use protected sex for 90 days post treatment if sexual partner is of child bearing potential. 26. Inability to provide legally effective Informed Consent Form (ICF) and/or comply with all the required follow-up requirements 27. Active infection in the urinary system 28. History of diabetes not controlled with a hemoglobin A1-C >7.0% 29. Diagnosed or suspected primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function, sphincter function or poor detrusor muscle function. 30. Visible hematuria with subject urine sample without known contributing factor
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Bladder Adenocarcinoma Bladder Clear Cell Adenocarcinoma Bladder Mixed Adenocarcinoma Bladder Neuroendocrine Carcinoma Bladder Small Cell Neuroendocrine Carcinoma Bladder Squamous Cell Carcinoma Bladder Urachal Adenocarcinoma Chromophobe Renal Cell Carcinoma Collecting Duct Carcinoma Infiltrating Bladder Lymphoepithelioma-Like Carcinoma Infiltrating Bladder Urothelial Carcinoma Infiltrating Bladder Urothelial Carcinoma With Giant Cells Infiltrating Bladder Urothelial Carcinoma, Nested Variant Infiltrating Bladder Urothelial Carcinoma, Plasmacytoid Variant Infiltrating Bladder Urothelial Carcinoma, Sarcomatoid Variant Kidney Medullary Carcinoma Large Cell Neuroendocrine Carcinoma Metastatic Bladder Carcinoma Metastatic Bladder Large Cell Neuroendocrine Carcinoma Metastatic Bladder Small Cell Neuroendocrine Carcinoma Metastatic Bladder Squamous Cell Carcinoma Metastatic Infiltrating Bladder Urothelial Carcinoma, Clear Cell Variant Metastatic Infiltrating Bladder Urothelial Carcinoma, Lipid-Rich Variant Metastatic Infiltrating Bladder Urothelial Carcinoma, Micropapillary Variant Metastatic Infiltrating Bladder Urothelial Carcinoma, Plasmacytoid Variant Metastatic Infiltrating Bladder Urothelial Carcinoma, Sarcomatoid Variant Metastatic Kidney Medullary Carcinoma Metastatic Malignant Genitourinary System Neoplasm Metastatic Penile Carcinoma Metastatic Prostate Small Cell Neuroendocrine Carcinoma Metastatic Sarcomatoid Renal Cell Carcinoma Metastatic Urethral Carcinoma Papillary Renal Cell Carcinoma Sarcomatoid Renal Cell Carcinoma Stage IV Bladder Cancer AJCC v8 Stage IV Penile Cancer AJCC v8 Stage IV Prostate Cancer AJCC v8 Stage IV Renal Cell Cancer AJCC v8 Stage IV Urethral Cancer AJCC v8 Stage IVA Bladder Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Bladder Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8 Testicular Leydig Cell Tumor Testicular Sertoli Cell Tumor Urethral Clear Cell Adenocarcinoma Metastatic disease defined as new or progressive lesions on cross-sectional imaging or bone scan. Patients must have at least One measurable site of disease as per Response Evaluation in Solid Tumors (RECIST) version (v) 1.1 One bone lesion on bone scan (tec99 or sodium fluoride [NaF] positron emission tomography [PET]/computed tomography [CT], CT, or magnetic resonance imaging [MRI]) for the bone-only cohort Histologically confirmed diagnosis of one of the following metastatic cohorts Small cell/ neuroendocrine carcinoma of the bladder All urothelial carcinomas with any amount of neuroendocrine differentiation (including small cell differentiation) will be included. If the tumor is purely neuroendocrine, metastasis from another site of origin should be clinically excluded Adenocarcinoma of the bladder, or urachal adenocarcinoma, or bladder/urethra clear cell adenocarcinoma must be pure (per World Health Organization [WHO] definition), (i.e. urothelial carcinoma with glandular differentiation is not considered a pure adenocarcinoma Squamous cell carcinoma of the bladder must be pure (i.e. urothelial carcinoma with squamous differentiation is not considered a pure squamous cell carcinoma)
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 20.0-80.0, Lumbar Spinal Stenosis to 80 years old Patients with a herniated disc, spinal stenosis Patients with chronic low back pain and lower extremity pain who did not respond to lumbar epidural steroid injections Patients who are performed percutaneous epidural neuroplasty with wire type catheter Incomplete medical record Contraindication to percutaneous epidural neuroplasty
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Hemostasis Pre-operative Patient is undergoing a non-emergent open gynecological, urological, ENT, head and neck, or vascular surgery Patient is willing and able to give prior written informed consent for investigation participation Patient is 18 years of age or older. Intra-operative Patient has one or more target bleeding sites (TBS) for which control of bleeding by conventional procedures is ineffective or impractical The TBS(s) has been treated with Bellows as per their instructions for use Patient is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding Patient has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent Patient has religious or other objections to porcine, bovine, or human components Patient has any significant coagulation disorder Patient has any other contraindications, warnings, precautions of the Approved Instruction For Use of Bellows preventing his/ her Patient is not appropriate for in the clinical trial, per the medical opinion of the Investigator
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Alcohol Use Disorder Alcohol Dependence Be at least 18 years of age. 2. Have a current (past 12 months) DSM-5 diagnosis of AUD (4 or more symptoms) assessed using the MINI neuropsychiatric interview version 7.0.2 (at least moderate severity, ICD-10-CM Code F10.20 alcohol dependence, uncomplicated). 3. Have a BAC by breathalyzer equal to 0.000 when s/he signed the informed consent document (either just prior to or immediately after signing consent). 4. Be seeking treatment for problems with alcohol reduction in drinking. 5. Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol. 6. Agree (if the subject is female and of child bearing potential) to use at least one of the following methods of birth control, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal: 1. oral contraceptives, 2. contraceptive sponge, 3. patch, 4. double barrier (diaphragm/spermicidal or condom/spermicidal), 5. intrauterine contraceptive system, 6. etonogestrel implant, 7. medroxyprogesterone acetate contraceptive injection, 8. complete abstinence from sexual intercourse, and/or 9. hormonal vaginal contraceptive ring. 7. Be able to take intranasal investigational products and be willing to adhere to the investigational product regimen. 8. Complete all assessments required at screening and baseline. 9. Have a place to live in the 2 weeks prior to randomization and not be at risk that s/he will lose his/her housing by Study Week 14. 10. Not anticipate any significant problems with transportation arrangements or available time to travel to the study site by Study Week 14. 11. Not have any plans to move within Study Week 14 to a location which would make continued participation in the study impractical. 12. Not have any unresolved legal problems that could jeopardize continuation or completion of the study. 13. Provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment. 14. Be someone who in the opinion of the investigator would be expected to complete the study protocol. 15. Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may substantially interfere with study participation. 16. If taking a medication for depression or anxiety, must have been taking a stable dose in the 2-months prior to randomization and plan to continue during the study. This includes drugs such as the following SSRIs Dual uptake inhibitors SNRIs Tricyclic antidepressants MAOIs Bupropion 17. Not currently taking oxytocin and agree not to take non-study oxytocin for the duration of the study Contact study site for
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-90.0, Stricture Esophageal Stricture Anastomotic Collagenosis The patient is 18-90 years old The patient suffers from dysphagia caused by an iatrogenic esophageal stricture The stricture is amenable for endoscopic dilation The patient has undergone at least 1 previous endoscopic dilation for the same stricture The patient has signed the ICF The patient is not fluent in Dutch
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-999.0, BPH BOO - Bladder Outflow Obstruction Age 50 or older 2. Verified BPH with prostate size of at least 30 grams or of 25 mm. 3. Signed Informed Consent 4. Failure, intolerance or patient non-compliance of medical treatment 5. Patients suffering from LUTS symptoms of BPH (IPSS >12, Qmax=<13 ml/sec) 6. Patient's voided volume of at least 125 ml in uroflow test 7. Patients not eligible for surgery or refusing surgery Known sensitivity to Nickel 2. Active Prostatitis 3. Urethral strictures 4. Prior surgery of prostate (simple or radical) 5. Currently active bladder tumor 6. Suspected neurogenic urinary bladder 7. Suspected a-contractile bladder 8. Enlarged median lobe of prostate. 9. Bladder Neck stricture or contracture 10. Urethral pathology: diverticula, strictures, tumors, fistula 11. Clinically Significant urinary tract infection 12. Uncontrolled bleeding disorders 13. Uncontrolled diabetes mellitus 14. Severe medical diseases precluding a minimally invasive procedure 15. Present active urinary stone disease 16. Patients who are under anticoagulants therapy
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 1.0-31.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Carcinoma, Renal Cell Patients who are 18 year-old or over who have been treated for metastatic renal cell carcinoma with sunitinib as first-line treatment (treatment with prior cytokine therapy is accepted) between 2007 and 30 September 2018 and who have obtained as a best treatment response the total remission of the disease in the opinion of the doctor in charge from a clinical, radiological and/or macroscopic point of view. This response must have been reached through two possible strategies: A) Systemic treatment with sunitinib alone. B) Treatment with sunitinib and subsequent local treatment for one or more residual lesions that have not responded to the drug (traditional surgery, radiotherapy, SBRT (Stereotactic Body Radiation Therapy)). 2. The duration of CR must have been confirmed with at least 2 consecutive imaging tests, without having a limit in the duration of this response. Although the patient had progressed subsequently, he/she may be included in this registry. 3. Patients from any risk group 4. Tumours of any histology Patients treated with another drug other than Sunitinib. 2. Patients with no radiology reports proving CR. 3. Patients with no record of the dose and regimen received with Sunitinib. 4. Patients who achieved complete remission after 30 September 2018
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Catheter Related Complication central venous catheter more than 48 hours in situ consent of a patient technical difficulties of ultrasound machine unfavorable local findings inflammation of skin, excoriation etc
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Cirrhosis Liver cirrhotic patients (any cause, any level) With acute decompensation Admitted in intensive care unit in Croix Rousse Hospital, Lyon, France Who receive as hemodynamic therapy Blood pressure monitoring thanks to an arterial line (radial, humeral or femoral) Urinary catheter, suprapubic catheter or any comparable device to monitor urine output The patient did not object to take part of the study Acute hemorrhage (Clinical definition or hemoglobin lower than 70g/L at admission) Patient requiring kidney replacement therapy Patient requiring invasive mechanical ventilation Any pathology that makes non-invasive ventriculo arterial coupling assessment impossible (non-sinus rhythm, severe valvular disease) Patient who objects to take part of the study
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 65.0-85.0, Hip Fractures Intertrochanteric Fractures Individuals between 65 and 85 years of age (inclusive of) at screening. 2. Intertrochanteric femoral fractures with American Society of Anesthesiology physical status 1, 2, or 3. 3. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments Hip fracture that requires total arthroplasty. 2. Patients transferred from other hospitals. 3. Patients that have other acute fractures. 4. Pre-existing dementia (Mini-Mental State examination score <20) or delirium (Mini-Mental State examination score <24). 5. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine, ropivacaine, acetaminophen, NSAIDs). 6. Serious systemic comorbidities that cause a contraindication for (severe hepatic or renal impairment) or ropivacaine. 7. Use of anticoagulants (including aspirin, except low dose aspirin). 8. Chronic opioid use of ≥ 20 morphine milligram equivalent (MME)/day for more than 7 days in the last 30 days. 9. Body Mass Index (BMI) <17 kg/m2 or >45 kg/m2. 10. Known history of renal or hepatic dysfunction, coagulation or bleeding disorder. 11. Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post-operative period for pain that is not strictly related to the surgery and which may confound the post-operative assessments based on the physician's discretion. 12. Clinically significant medical disease that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other conditions that would constitute a contraindication to participation in the study. 13. History of suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years. 14. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study. 15. Previous participation in an study. 16. Resident of a skilled nursing facility (SNF), long-term acute care (LTAC) facility, inpatient rehabilitation facility (IRF), or nursing home. Participants from assisted living facilities will be eligible for the study. In addition, the subject may be withdrawn from the study if the subject meets the following during the hospital stay: 17. Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's post-operative course. 18. Subjects who undergo hip fracture surgery more than 30 hours after admission to the Emergency Department
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 40.0-70.0, Prostatic Hyperplasia Male patients presenting with lower urinary tract symptoms to urology outpatient clinic 2. According to the European Association of Urology Guidelines: 1. International prostate symptom score> 8 2. Prostate volume> 40 ml 3. Q max <15 ml /sn 3. Patients who did not receive any treatment for lower urinary tract symptoms and applied for the first time 4. Patients who have not undergone lower urinary tract surgery Patients who had undergone medical and surgical treatment for lower urinary tract symptoms 2. Patients with accompanying urethral stricture 3. Patients with neurological diseases (Parkinson's, Multiple Sclerosis etc ...) 4. Patients with spinal cord trauma 5. Patients with indication for surgical treatment at the time of initial admission (Macroscopic hematuria, bladder stone, urinary retention, upper urinary tract dilatation)
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Urethral Stricture Urethral Stricture Diagnosis Indication for buccal mucosa graft urethroplasty Accept the Informed Consent Term (patient or responsible) Severe urethral stricture which a two-staged procedure are required Long strictures which need a both types of buccal mucosa graft due its length Refuse to ICT for the patient ou it responsible
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 45.0-90.0, Voiding Disorders Controls (n=13) Men older than 45 years undergoing radical prostatectomy without LUTS IPSS (International prostate symptom score lower than 12) Nocturia equal or less than 2 on a two day bladder diary Group 1 (n=18) Men older than 45 with improved LUTS after 6 months of a BOO procedure and IPSS less than 12 Improvement in IPSS in at least 3 points for storage symptoms Nocturia equal or less than 2 on a two day bladder diary Group 2 (n=9) Men older than 45 with persistent LUTS at six months post BOO procedure IPSS higher than 8 Nocturia more than 2 Delta change in IPSS score less than negative 3 points Men with Neurogenic bladder Urethral stricture Prior BOO procedures History of urinary retention with indwelling foley catheter or intermittent catheterization Additional for Group 1 and 2 (Subjects with BPH and LUTS) History of bladder cancer within 5 years History of treatment for prostate cancer other than active surveillance Intradetrusor injection of BTX-A within 9 months prior to screening for any urological condition
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 40.0-999.0, BPH Subject signed informed consent form (ICF) Age 40 and above Male with symptomatic BPH IPSS symptom severity score ≥ 13 Peak urinary flow of < 12 ml/sec Prostate volume between 25 ml to 80 ml (assessed by pre-operative ultrasound TRUS) Blood CBC and biochemistry up to two weeks before screening, demonstrating: Normal values of the PT, PTT and INR tests (Anticoagulants washout may be done two weeks prior of device implantation) Subject able to comply with the study protocol Normal urinalysis and negative urine culture A post void residual (PVR) volume > 250 ml measured by ultrasound or acute urinary retention Confirmed or suspected bladder cancer Recent (within 3 months) cystolithiasis or hematuria Urethral strictures, bladder neck contracture, urinary bladder stones or other potentially confounding bladder pathology An active urinary tract infection Enrolled in another treatment trial for any disease within the past 30 days Previous colo rectal surgery (other than hemorrhoidectomy) or history of rectal disease if the therapy may potentially cause injury to sites of previous rectal surgery, e.g., if a transrectal probe is used Previous pelvic irradiation, cryosurgery or radical pelvic surgery Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Urologic Neoplasms Age > 20, Japanese men and women Patients who have started at least 1 cycle of chemotherapy Patients who provided informed consent by appropriate methods. In dead case, optout will be applicable Patients who are diagnosed as stage IV (T4b, any N or any T, N2-3 or M1) UC between January 1st in 2017 and December 31st in 2018 Patients who have FFPE primary tumor sample collected after January 1st in 2017. The sample should be collected before any therapies including 1st line treatment in stage IV and therapies in stage III and other stages. It is possible to send sliced undyed section of primary tumor including 1 HE-stained section of same sample in case that patients cannot send FFPE primary tumor block -Patients who are prior exposure to immune-mediated therapy as 1st line treatment in stage IV
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-99.0, Bleeding Stricture Grade III and grade IV hemorrhoid Anal fistula, rectal polyo\p
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Neurogenic Bladder Urinary Retention Urologic Diseases Males age ≥ 18 with clinical diagnosis of significant urinary retention 2. Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling strategy 1. Must have stable urinary management history as determined by the investigator OR: 2. Must have urodynamic profile suitable for Gen 2 Connected Catheter (including bladder capacity > 200mL without uninhibited bladder contractions) 3. Subject's lower urinary tract anatomy must fall within the ranges serviceable by the Gen 2 Connected Catheter device, as specified in the Investigational Device Instructions for Use (IFU) Active symptomatic urinary tract infection, as defined in this clinical investigation protocol (subjects may receive the device after UTI has been treated) 2. Significant risk profile or recent history of urethral stricture (e.g. stricture within past 90 days) 3. Significant risk profile or recent history of clinically significant (uncontrolled) autonomic dysreflexia 4. Significant intermittent urinary incontinence (between catheterizations) 5. Uninhibited bladder contractions and/or Vesicoureteral reflux that is not reliably controlled with medication or alternate therapy (e.g. Botox injection) 6. Pre-existing urinary pathologies and/or morphological abnormalities of the lower urinary tract or bladder (assessed during in-depth medical screening, including cystoscopy and urine analysis) 1. Urinary tract inflammation or neoplasm 2. Urinary fistula 3. Bladder diverticulum (outpouching) > 5cm in size 4. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months) 5. Impaired kidney function or renal failure 6. Active gross hematuria 7. Active urethritis
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-100.0, Colon Cancer Any patient who understands, agrees to participate and signs the informed consent older than 18 years-old electively operated and programmed laparoscopically of the colon and upper rectum in which peritoneal reflection has not been opened duration of the surgical act less than 180 minutes Prior anesthetic assessment of ASA I-III International prostate symptom score (IPSS) of less than 19 with / without treatment for BPH (alpha-blocker) Open surgery or conversion to open surgery Performing periodic anesthesia or being ASA IV Preoperative diagnosis of recurrent urinary tract infections (more than 3 episodes / year documented by urinoculture or two urinary tract infections in the last 6 months) Moderate-severe prostate clinic (IPSS> 19) Presence of positive urine culture in men in preoperative tests Urinary infection clinic in women with positive urine culture Previous history of acute urine retention be a permanent bladder catheter or ureteral catheter and perform intermittent autocatheterization men who underwent prostate surgery patients with a history of treatment for urological tumor
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 6.0-100.0, Urethral Stricture Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations Patient age ≥ 6 years If a patient reaches the age of 18 years, he or she will have to provide a new voluntarily signed written informed consent. All patients reaching the age of 18 years will be contacted by the Principal Investigator or Subinvestigator to provide a new voluntarily signed written informed consent Absence of signed written informed consent and thus a patient unwilling to participate
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Benign Prostatic Hyperplasia Post-Op Complication Embolization Therapeutic Transurethral Resection of Prostate Syndrome LUTS from Benign Prostate Hyperplasia (BPH) with moderate and severe IPSS score (IPSS > 8) and QoL = or >3 and refractory to medical treatment for at least 6 months or the patient is unwilling to accept medical treatment or BPH using permanent or intermittent catheterization Prostate volume > 50 ml Signed informed consent Urological disorders: evidence of clinically significant prostate cancer [as defined by START criteria] on prostate biopsy (27,28), prostatitis (29,30), detrusor-sphincter dyssynergia or evidence of neurogenic bladder, urethral strictures, bladder neck contracture, bladder stone or bladder cancer Renal insufficiency defined as Glomerular Filtration Rate < 30 ml/min/1,73m2 Known severe reactions to iodine-based contrast or gadolinium-based contrast Previous prostate operation CT examination reveals no access to the prostate arteries
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Pelvic Organ Prolapse de Novo Stress Urinary Incontinence Stress Urinary Incontinence Anterior, uterine or apical prolapse with a POP-Q stage II or more requiring surgical correction Stress urinary incontinence (SUI) on history Previous anti-incontinence surgery Pregnancy Prior urethral repair surgery (diverticulum, fistula) Women declining the use of any mesh product or a mid-urethral sling procedure Absolute contraindication to MUS (pelvic kidney, vascular graft, low ventral hernias) Women who do not speak or read English or French Isolated posterior compartment prolapse Geographic location preventing women to come to 6 week and 6 month appointments
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Non-muscle Invasive Bladder Cancer Urinary Biomarker Age ≥18 years of age at the time of signing the Informed Consent Form Ability to understand the Participant Information sheet orally and in writing Signed Informed Consent Form Is, according to the investigator's judgement, able to comply with the trial protocol Previously diagnosed with high grade NMIBC Recurrence free at the time of detected by flexible cystoscopy History of any upper urinary tract tumor regardless of grade and stage within the last 5 years prior to randomization T1 tumor where re-resection has not been performed CIS or invasive tumor within 3 months before randomization
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 45.0-999.0, Overactive Bladder Participant has completed participation of the 24-week double-blind treatment period in Study URO-901-3005 (NCT03902080) and demonstrated compliance with the study procedures and study medication schedule in the opinion of the investigator Participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Participant has the ability to continue to receive a stable dose of Benign Prostatic Hyperplasia (BPH) treatment with either a) alpha blocker monotherapy or b) alpha blocker +5-ARI In the opinion of the investigator, the participant is able and willing to comply with the requirements of the protocol, including completing study questionnaires and the Bladder Diary Participant experienced any Serious Adverse Event in Study URO-901-3005 that was reported as "possibly or probably related" to study treatment by the investigator Participant is using any prohibited medications Participant has uncontrolled hyperglycemia (defined as fasting blood glucose >150 milligrams per deciliter [mg/dL] or 8.33 millimoles per Liter [mmol/L] and/or non-fasting blood glucose >200 mg/dL or 11.1 mmol/L) based on most recent available lab results in Study URO-901-3005 or uncontrolled in the opinion of the investigator Participant has uncontrolled hypertension (systolic blood pressure of ≥180 millimeters of mercury [mmHg] and/or diastolic blood pressure of ≥100 mmHg) or has a resting heart rate (by pulse) >100 beats per minute Participant has systolic blood pressures ≥160 mmHg but <180 mmHg, unless deemed by the investigator as safe to proceed in this study and able to complete the study per protocol Participant has current evidence of any clinically significant condition, therapy, lab abnormality, or other circumstances that might, in the opinion of the investigator, confound the results of the study, interfere with the participant's ability to comply with study procedures, or make participation in the study not in the participant's best interest
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-70.0, Benign Prostatic Hyperplasia Ambulatory male patients between 50 to 70 years and had diagnosis of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH) International prostate symptoms score (IPSS)≥ 8 Peak urinary flow rate (Qmax)<15ml/sec for a voided volume of 150 ml or more Post voidal residual urine volume ≥ 50 ml (by transabdominal ultrasonogram) Volume of prostate determine by transabdominal ultrasonogram ≥ 30 gm History of prostate cancer/raised PSA>4 ng/ml Previous prostate surgery /Periurethral surgery Patient undergone surgery to the bladder neck/Bladder neck contracture Urethral stricture History of LUTS not due to benign prostatic hyperplasia (BPH) Postvoid residual urine volume of >150ml Bladder stone Active urinary tract infection which might affect micturition Large intravesical protrusion > 2 cm Known hypersensitivity or history of active substance abuse
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-85.0, Ureteral Stricture Benign diseases: UPJ, ischemic injury caused by surgical separation, endoscopic surgery injury, heat injury by laser lithotripsy, infection (chronic inflammation, tuberculosis), peri-ureteral fibrosis caused by endometriosis, ureteral anastomotic stenosis after renal transplantation, ureteral fistula, multiple polyps; 2. Malignant diseases: ureteral anastomotic stricture after urinary diversion, stricture caused by compression of abdominal and/or pelvic tumors, stricture caused by urinary tract tumors, stricture caused by radiotherapy for colon or cervical cancer, ureteral fistula Combine with hypertonic neurogenic bladder (except for patients with long-term indwelling catheter) 2. Colon resection surgery patients -
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 45.0-999.0, BPH With Urinary Obstruction Male Patients suffering from LUTS secondary to infravesical obstruction from BPH failed medical treatment International Prostate Symptom Score (IPSS) > 13 a peak urinary flow rate (Qmax) < 15 ml/sec a prostate size ≥ 75 gm presence of a urethral stricture neurological disorder bladder cancer prostate cancer previous history of bladder neck surgery or TURP
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Hernia, Ventral Hernia Incisional Acute Kidney Injury Restrictive Lung Disease Intraabdominal Hypertension Horizontal fascial defects of >8 cm defined by preoperative CT scan Planned elective open incisional hernia repair Pregnancy Previous bladder resection or reconstruction Chronic catheter use Inability to provide informed consent
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 7.0-16.0, Dysfunctional Voiding Stress Incontinence, Urinary All subjects • Age 7-16 years inclusive Controls Concurrent urological disease requiring surgery which includes cystoscopy No significant urinary symptoms No day-time urinary incontinence Urinary frequency 4-7 per day No history of recurrent urinary infections (more than two infections in previous year) Has not passed a renal tract stone Overactive sphincter Require VCMG as part of their clinical care A prior diagnosis of dysfunctional voiding. This will have been made in a neurologically intact child following previous non-invasive bladder investigation including two representative urine flows that demonstrate the following (Austin et al., 2014) Intermittent and/or fluctuating flow rate Unaccompanied by adult with parental responsibility who can give consent Previous bladder outlet or urethral surgery Other urological disease not mentioned specifically in the treatment group criteria; including posterior urethral valves, cerebral palsy, inherited metabolic disease Contraindication to Entonox if sedation required for catheter insertion Conditions where gas may be trapped in a body cavity, eg middle ear occlusion, intestinal obstruction Unable to understand instruction for use of Entonox Evidence urinary tract infection on day UPP measurement Symptoms of dysuria Abnormally cloudy or offensive urine Temperature of 38oc or more
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 19.0-80.0, Urological Disease Radical Cystectomy Between 19 and 80 years old 2. Persons requiring urethral catheterization for more than 2 weeks after surgery * due to urological diseases * Radical cystectomy 3. Subjects who voluntarily decided to participate and signed the written informed consent 4. A person who can understand and follow the instructions and participate in the pre-clinical period A person with a congenital abnormality in the urinary or reproductive system 2. Immunodeficiency disease (eg HIV infected) 3. Urinary tract fistula 4. Allergic history of the material used in the catheter 5. Symptomatic UTI by baseline time point 6. Dermatitis at the catheter insertion site 7. Pregnant or lactating women 8. A person who does not agree to contraceptive * in a medically accepted manner until the end of the study and 4 weeks after the end of the study. Medically acceptable contraceptive methods: condoms, oral contraceptives lasting at least 12 weeks, injectable or injectable contraceptives, intrauterine contraceptives, etc. 9. Inappropriate participation in the study, as determined by the investigator or investigator, as it may affect ethical or clinical trial results. 10. Patients on anti-thrombotic medication (excluding low-dose aspirin (100 mg, up to 300 mg / day))
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 40.0-999.0, Urinary Catheterization Thoracic Surgery Thoracic Epidural Analgesia Male patients greater than the age of 40 and/or with type 2 diabetes undergoing pulmonary surgery who did not undergo straight or indwelling urinary catheterization intraoperatively. OR 2. Male patients receiving a thoracic epidural analgesia undergoing pulmonary surgery who did not undergo straight or indwelling urinary catheterization intraoperatively Active treatment of Benign Prostatic Hyperplasia (BPH) 2. Hypersensitivity or allergy to tamsulosin HCL 3. Active treatment with tamsulosin or other alpha-blocker or uses of tamsulosin/ other alpha-blocker within 3 weeks of enrollment date 4. Active urinary tract infection 5. History of urological disorder specified as urethral stricture, BPH, bladder or prostate malignancy 6. History of urological surgery (Transurethral resection of the Prostate, Transurethral resection of the Bladder, Bladder suspension, prostatectomy) 7. Underlying neurological disorders resulting in impaired bladder function 8. Any known contraindication to the use of tamsulosin HCL
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-99.0, Urethral Stricture Fat Graft Urethral stricture that has re-occurred at least once Malignant etiology of urethral stricture
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2
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Cystoscope Lower Urinary Tract Symptoms Bladder Disease Adults (males and females), ≥18 years of age or older, presenting for cystoscopy Ambulatory with a need to undergo cystoscopy for diagnostic or therapeutic purposes Willing to participate in a clinical trial History of high-grade bladder cancer or carcinoma-in-situ of the bladder, undergoing cystoscopy for follow-up/surveillance purposes History of prior bladder/urethral reconstructive surgery Presence of symptomatic urinary tract infection (UTI) Known unpassable urethral stricture Unable to read and/or understand the study requirements Unable or unwilling to provide consent to participation in the study Pregnant or lactating women
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-80.0, Pain, Procedural Male Undergoing flexible cystocopy at University Health Network that have undergone a flexible cystocopy and did not demonstrate difficulty during exploration (meatal stenosis or urethral stricture), simultaneous removal or ureteral stents or bladder biopsies or have a chronic history of pelvic pain Patients that do not meet the criteria
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 45.0-999.0, Benign Prostatic Hyperplasia Patients evaluated in the urology department and candidates to surgical treatment Age > 45 years IPSS ≥ 10 Maximum urinary flow < 12 milliliters (mL)/second (s) Post-void residual urinary volume < 300mL Prostatic volume between 20mL and 250mL assessed by ultrasound Signed informed consent PSA > 10 (if not negative prostate biopsy) Life expectancy below 1 year Renal insufficiency defined as Glomerular Filtration Rate < 30 ml/min/1,73m2 Known severe reactions to iodine-based contrast or gadolinium-based contrast CT examination reveals no access to the prostate arteries
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 40.0-80.0, Benign Prostatic Hyperplasia (BPH) Male aged 40-80 years old 2. 7 ≤ IPSS score <19 3. The subject did not take α-blocker or anticholinergic agents in the last 8 weeks. The subject did not take 5α-reductase inhibitor or androgen suppression agents in the last 16 weeks (depending on medical history). 4. The subject isn't diagnosed with cancer 5. The subject is able to read and finish the information on the questionnaire. 6. The subject must read and sign the informed consent form after the study has been fully explained The subject has a history of epilepsy or convulsions, liver and kidney disease, cancer, endocrine disease, mental illness, alcohol or drug abuse, and other major organic diseases (depending on medical history). 2. The lower urinary tract urination symptoms of the subject are not related to prostatic hypertrophy (depending on medical history). 3. Residual urine volume > 250 mL (depending on medical history) 4. Subjects have had pelvic radiation therapy or pelvic surgery (including prostate or bladder surgery, but those who only have had a prostate slice can participate in the trial). 5. Subjects have taken sexual hormone preparations including LHRH agonists, anti-androgens, feminine, or Penta-reductase inhibitors (Proscar and Avodart) 16 weeks prior to the trial. 6. Subjects have participated in other clinical trials 12 weeks prior to the trial
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Prostate Hyperplasia Men who are fit for surgery and need a surgical resection of the prostate larger than 80 ml including: 1. Bothersome LUTS with an IPSS score over 19 2. Refractory hematuria 3. Upper urinary tract affection 4. Recurrent UTI secondary to prostatic enlargement 5. Maximum uroflow rate (Qmax) below 10 ml/sec. 6. bladder diverticula 7. Urinary retention whether recurrent acute attacks with failure of medical treatment or chronic retention Patients with: 1. Neurogenic bladder 2. Previous prostate or urethral surgery 3. Associated urethral stricture 4. Prostate cancer diagnosed by TRUS biopsy 5. Bladder stones
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Neuromuscular Diseases Hemiparesis "Eligible couples must present all the following Signing of the informed consent form Men and women aged from 18 Single stroke hemiparetic patient, or patient with neuro-muscular disease, or healthy subject free of neurological disorder and other disease Patient able to stand alone at least 30 seconds without technical assistance (multiple repetitions) To be included, patient should not present any of the following Bilateral brain injury, cerebellar syndrome Other disease or defect that may interfere with the study such as visual, vestibular or other related uncontrolled medical condition Major cognitive impairment that does not allow evaluation Pregnant women, breastfeeding Non affiliated to a social security scheme"
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Anesthesia Urologic Diseases patients above the age of 30 years patients who were admitted for minor urological surgeries under the care of urology team. Minor urological procedures, included cystoscopy, trans-urethral resection of tumor (TURT), uretroscopy, double J insertion, and double J removal patient refusal urgent and emergency cases, which were not elective procedures Surgeries that were expected to take a long duration (more than 1.5 hour)
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 40.0-85.0, Glaucoma Open-Angle Primary Cataract General 1. Male and female patients, from 40 to 85 years of age, inclusive. 2. Patient is able and willing to attend scheduled follow-up examinations as per routine care for 2 year post-operatively. 3. Patient is able to understand the information sheet and give informed consent. for the study eye: 4. An operable age-related cataract with BCVA of 6/9 or worse that is eligible for phacoemulsification. 5. A diagnosis of POAG or pigmentary glaucoma treated with hypotensive medications (eye drops for glaucoma). 6. A previously documented unmedicated intraocular pressure of > 21 mmHg (i.e. IOP > 21 mmHg prior to the commencement of glaucoma treatment). 7. An optic nerve appearance characteristic of glaucoma with either: 1. visual field loss (no worse than -12dB) identified on examination using Humphrey 24-2 SITA standard, or 2. (in patients where the VF exam is not confirmatory for glaucomatous defect) OCT retinal nerve fibre layer imaging supporting the ophthalmoscopy findings indicating a diagnosis of mild glaucoma. (If OCT findings are not confirmatory of glaucoma and both the visual field and the OCT are normal, the patient should not be enrolled). 8. Shaffer grade ≥2 in all four quadrants on gonioscopy. 9. Absence of peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities that could impair surgical access to the ciliary processes Diagnosis of Primary angle closure glaucoma. 2. Any diabetic retinopathy. 3. Previous history of Central Serous Retinopathy or Cystoid Macular Oedema in either eye. 4. Congenital or developmental glaucoma. 5. Secondary glaucoma (such as neovascular, uveitic, pseudoexfoliative, lens-induced, steroid-induced, trauma induced, or glaucoma associated with increased episcleral venous pressure). 6. Previous trabeculectomy, tube shunts, or any other prior subconjunctival filtration or cycloderstructive surgery. 7. Inability to complete a reliable 24-2 SITA Standard Humphrey visual field on the study eye at screening (fixation losses, false positive errors and false negative errors should not be greater than 33%). 8. Patients with advanced glaucoma or any patient where the risk to the patient of a washout of ocular hypotensive medications (eye drops for glaucoma) is assessed as unacceptable (i.e. where there may be a risk of damage to vision if treatment is stopped for the washout). 9. Best corrected visual acuity worse than 6/36 in the fellow eye (i.e. not the eye undergoing the study intervention). 10. A 24-2 SITA Standard Humphrey visual field mean deviation (MD) of worse than -12dB in the study eye. 11. Previous vitreo-retinal surgery. 12. Previous corneal surgery or clinically significant corneal dystrophy, e.g. Fuch's dystrophy (>12 confluent guttae). 13. Unclear ocular media preventing visualization of the fundus or anterior chamber angle. 14. Degenerative visual disorders such as wet age-related macular degeneration. 15. Clinically significant ocular pathology other than cataract and glaucoma. 16. Clinically significant ocular inflammation or infection within 1 month prior to screening. 17. Presence of extensive iris processes that obscure visualization of the trabecular meshwork. 18. Uncontrolled systemic disease that in the opinion of the investigator would put the patient's health at risk and/or prevent the patient from completing all study visits. 19. Current participation or participation within the past 30 calendar days in another investigational drug or device clinical trial (which includes the fellow eye). 20. Pregnant or nursing women, or women of child bearing age planning pregnancy or not using medically acceptable contraceptives. 21. Unwilling or unable to give informed consent/unwilling to accept randomisation. 22. Unwilling or unable to return for scheduled protocol visits. 23. Any not met
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urethral Stricture Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations (Appendix B) Age ≥ 18 years Male patient Anterior urethral stricture disease (penile, bulbar, penobulbar and panurethral strictures are allowed) Procedure was ended with leaving a transurethral catheter in place with foreseen catheter removal and early postoperative imaging after x days Absence of signed written informed consent (Appendix B) Age < 18 years Female patients Transgender patients Posterior urethral stenosis Bladder neck reconstruction Patients in which no catheter has been left in place at the end of the procedure Patients in which there is no need for early postoperative imaging, upon discretion of the treating clinician
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 20.0-80.0, Retrograde Bladder Fill Any male patient between ages 20-80 with foley catheter indwelled after urological surgery performed at our institution Any patient that does not remove foley catheter at discharge
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2
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urothelial Carcinoma Bladder Cancer Urothelial carcinoma group Any male or female patient aged 18 or older Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments Diagnosed with incident or recurrent urothelial carcinoma (including bladder/ureter/renal pelvis) by surgery. 2. interference group Any male or female patient aged 18 or older Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments Diagnosed with incident or recurrent bladder cancer other than urothelial carcinoma (including bladder squamous cell carcinoma/bladder adenocarcinoma/other bladder-related cancers/prostate cancer/rectal cancer) by surgery. 3. Control group Any male or female patient aged 18 or older Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments Diagnosed with urinary disease such as Urinary calculi, urinary tract infection (except urinary tuberculosis), benign prostatic hyperplasia, glandular cystitis. All enrollee are able to provide legally effective informed consent. 4. Healthy volunteers group Urothelial carcinoma/Interference group/Control group Has had diagnosed with other cancers Patients diagnosed with non-urological cancer Failed to provide a written informed consent. 2. Healthy volunteers group Volunteers with abnormal test results of urine analysis or urological ultrasound test Volunteers sceptical of cancers from non-urological origin in a normal results of urine analysis or urological ultrasound Failed to provide legally effective informed consent
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-999.0, Prostate Obstruction Prostatic Hyperplasia Prostatic Hypertrophy, Benign patients with Qmax of less than 15 mL/second due to BPH, severe LUTS/BPH requiring surgical treatment, and International Prostate Symptom Score (IPSS)>7 due to BPH prostate and/or bladder cancer, bladder diverticula, urethral stricture, active urinary tract infection (UTI), unless treated, and men with neurogenic voiding dysfunction
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-100.0, Prostate Cancer Adult Chinese male patients with age > 18 years old Clinical indicated for prostate cancer detection and has serum PSA level done within 8 weeks of urine test Patient with recent urinary tract infection within 6 weeks prior to urine collection Patient with recent urethral instrumentation, such as Foley catheter insertion, cystoscopy etc., within 6 weeks prior to urine collection Patient with consumption of 5 alpha reductase inhibitors in past 6 months Patient refused or unable to provide consent for the study
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-80.0, Benign Prostatic Hyperplasia Men aged between 50 years clinically indicated for surgical treatment Patients with active urinary tract infection or in retention of urine Patients with bleeding disorder or on anti-coagulation Patients with bladder pathology including bladder stone and bladder cancer Patients with urethral stricture Patients with neurogenic bladder and/or sphincter abnormalities Patients with previous nonpharmacological prostate treatment, Prostate cancer Fail to give informed consent
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia male patients with LUTS/BPH prostate size > 25 g urinary retention diabetes mellitus neurologic deficit LUTS medications prior lower urinary tract surgery concomitant bladder pathology small bladder capacity (< 150 ml) urethral stricture evident prostate carcinoma
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Urethral Stricture patients who will be 2 years or more out of surgery patients with incomplete medical records or follow-up informations
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 45.0-90.0, Urinary Retention All men with benign prostate hyperplasia who planned to undergo TURP will be included in this study Large post void residual urine Simultaneous internal urethrotomy and TURP Uncontrolled Diabetes Mellitus (DM) Cerebrovascular accident accident (CVA) Spinal cord injury
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-80.0, Prostate Neoplasm Men more than 18 years old with clinical suspicion of prostate cancer Serum PSA ≤ 20 ng/ml within the previous 3 months Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis Able to provide written informed consent Prior prostate biopsy or prostate surgery Prior treatment for prostate cancer Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min) Contraindication to prostate biopsy
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0
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