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Composition of the data monitoring committee, its role, and reporting structure {21a}
The data and safety monitoring board include an independent statistician, a clinical expert in neonatology, and two representatives of preterm infant parent organisations. The role of the data and safety monitoring board is to monitor the progress of the trial and to ensure that the conduct of the trial is safe and eth...
PMC10523706
Adverse event reporting and harms {22}
NEC, ROP, pneumothorax, IVH, deaths, FIP, PVL
ADVERSE REACTIONS, PRETERM BIRTH, INTRAVENTRICULAR HAEMORRHAGE, NECROTISING ENTEROCOLITIS, PNEUMOTHORAX, ADVERSE EVENTS, FIP, COMPLICATIONS
Preterm infants are a vulnerable group of patients and a high number of adverse events was anticipated in the pro.LISA trial. Typical complications of preterm birth (e.g. intraventricular haemorrhage, surgery due to necrotising enterocolitis) were defined as adverse events, are collected systematically, and are entered...
PMC10523706
Frequency and plans for auditing trial conduct {23}
Trial institutions, facilities, and all data on electronic case record forms must always be available for inspection by an authority. Online monitoring of electronic case record forms is done by the trial management group on a continuous basis. Close out of centres after completed enrolment will be done by personnel vi...
PMC10523706
Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}
Changes and additions to the protocol will be submitted to the ethics committees of all participating centres and regulators for review and approval. Thereafter, changes are communicated to participating sites and—if necessary—to parents of trial participants.
PMC10523706
Dissemination plans {31a}
COMPLICATIONS
In general, results from the study will only be published after the database has been closed. Exceptions are publications concerning the design of the study and descriptive results of safety analysis after discharge from the hospital of all enrolled infants. The latter is planned, since the primary endpoint will be mea...
PMC10523706
Discussion
BPD, respiratory distress syndrome
PRETERM BIRTH, RESPIRATORY DISTRESS SYNDROME, COMPLICATIONS
In meta-analyses of randomised controlled trials, surfactant application via LISA is superior to surfactant application via an endotracheal tube in terms of mechanical ventilation within the first 72 h of life, BPD, other complications of preterm birth, and mortality [Important uncertainties persist with regard to the ...
PMC10523706
Trial status
RECRUITMENT
The current protocol version number is Pro.LISA_01_31 version 4 from 11 January 2023. The pro.LISA trial started enrolment in February 2022. The approximate date when recruitment will be completed is the year 2024.
PMC10523706
Acknowledgements 
Participating investigators of the pro.LISA study group (all in Germany).
PMC10523706
Authors’ contributions {31b}
WG
WG, TKR, EH, IRK, and GS designed the study and wrote the first draft version. All authors made substantial contributions to the study protocol and the manuscript. TKR and IRK were responsible for the statistical study planning. All authors revised the first draft version of the manuscript, approved the final version, ...
PMC10523706
Funding {4}
Open Access funding enabled and organized by Projekt DEAL. The pro.LISA trial is funded by the German Federal Ministry of Research and Education (No.: 01KG2024).
PMC10523706
Availability of data and materials {29}
WG
SECONDARY
After analysis and publication of the primary and secondary outcome data, full access to de-identified patient-level outcome data, the full protocol of the trial, and the statistical code will be available upon reasonable request from the principal investigator (WG).
PMC10523706
Declarations
PMC10523706
Ethics approval and consent to participate {24}
Written informed consent to participate will be obtained from all legal guardians of preterm infants participating in the pro.LISA trial. The pro.LISA trial was approved by the Ethics Committee of the University of Lübeck (No.: 21–422) and by ethics committees of all participating sites.
PMC10523706
Consent for publication {32}
A consent form which is revised and adapted by the Ethics Committees of participating centres is part of the informed consent process. This consent form includes information about the purpose of the trial, the potential benefits and risks, the right to refuse participation or to withdraw consent at any time, the instit...
PMC10523706
Competing interests {28}
WG
WG, IRK, and EH report grants from the Federal Ministry of Education and Research, Germany. WG, EH, and GS report personal fees from Chiesi Farmaceutici SpA outside the submitted work. All other authors declare that they have no competing interests.
PMC10523706
References
PMC10523706
2. Materials and Methods
PMC9961876
2.1. Study Design
edentulous
A double-blinded, interventional, non-randomized control trial was conducted in the Aligarh Province (Uttar Pradesh, India) between 2017 and 2019. This study aimed to evaluate the role of vitamin D on masticatory muscle activity among completely edentulous patients and its effect on the retention of dentures as perceiv...
PMC9961876
2.2. Study Subjects and Sample Size
edentulous, temporomandibular disorders
TEMPOROMANDIBULAR DISORDERS, TEMPOROMANDIBULAR DISORDERS
A total of 130 completely edentulous patients between the ages of 38 and 75 were recruited for the study. Subjects were evaluated for temporomandibular disorders according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) [
PMC9961876
2.3. Methodology
bite clenching, denture, RCD
SECONDARY
In the present study, the assessments were done at three points in time: at 0 months (T0); 3 months (T3) and 6 months (T6).Pre-intervention—At T0-S Vit D, USG and sEMG values were recorded for each enrolled subject. Based on S Vit D levels, only treatment group subjects were recommended the Vitamin D oral supplements.I...
PMC9961876
Recording of S Vit D, USG, and sEMG
PAD, PATHOLOGY, CONTRACTION
Measurement of S Vit DThe institute’s medical pathology laboratory support was taken for the test. The trained technician blinded from the study collected the blood sample from each subject. The liquid chromatography-tandem mass spectroscopy (LC-MS) was applied for the direct measurement of 25(OH)D [25-hydroxyvitamin D...
PMC9961876
2.4. Statistical Methods
denture
Descriptive characteristics were determined for each variable. The mean ± standard deviation (sd) was reported for continuous variables, while the total frequency (percentage) was written for categorical variables. Pearson correlation and Spearman correlation coefficients were calculated for continuous and categorical ...
PMC9961876
4. Discussion
bone disease, RCDs, denture, masseter muscle thickness, tooth loss, deficiency-related ailments, eating habits
BONE DISEASE, OTHER NUTRITIONAL DEFICIENCY
In the present study, it was found that demographic and occupational variations have an impact on S Vit D levels [At enrolment, S Vit D levels ranged from 5.5 to 41.5 ng/mL in the study population. After intervention at 3 months, S Vit D levels range improved from 12.5 to 75.80 ng/mL. Initially, only 3 (2.3%) had S Vit...
PMC9961876
Author Contributions
Conceptualization, S.R., S.C. and S.A.; methodology, S.R., S.C., S.A., G.R., N.M.A., M.C., V.G., R.S., S.S.B. and G.M.; software, S.R., S.C., S.A., G.R., N.M.A., M.C., V.G., R.S., S.S.B. and G.M.; validation, S.R., S.C., S.A., G.R., N.M.A., M.C., V.G., R.S., S.S.B. and G.M.; formal analysis, S.R., S.C. and S.A.; invest...
PMC9961876
Institutional Review Board Statement
The study was conducted in accordance with the Declaration of Helsinki, and the protocol was approved by the Ethics Committee of the Institute. JNMC, AMU, Aligarh, India [JNMC-AMU/ECL/22-2013-14].
PMC9961876
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
PMC9961876
Data Availability Statement
Data can be made available on demand by the chief researcher for academic purposes by email.
PMC9961876
Conflicts of Interest
The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.
PMC9961876
References
denture
Maximum scores about responses for denture retention as perceived by patients at different levels.Descriptive Characteristics and Correlation with each time of recording of Vitamin D.Mean ± standard deviation is represented for continuous variables and N (%) are depicted for categorical variables. ‘rCorrelation coeffic...
PMC9961876
Background
dry eye disease
DISEASE
Using traditional patient-reported outcomes (PROs), such as paper-based questionnaires, is cumbersome in the era of web-based medical consultation and telemedicine. Electronic PROs may reduce the burden on patients if implemented widely. Considering promising reports of DryEyeRhythm, our in-house mHealth smartphone app...
PMC10436120
Objective
The purpose of this study is to assess the equivalence between smartphone app–based and paper-based questionnaires for DED.
PMC10436120
Methods
This prospective, nonblinded, randomized crossover study enrolled 34 participants between April 2022 and June 2022 at a university hospital in Japan. The participants were allocated randomly into 2 groups in a 1:1 ratio. The paper-app group initially responded to the paper-based Japanese version of the OSDI (J-OSDI), f...
PMC10436120
Results
A total of 33 participants were included in this study. The total scores for the app- and paper-based J-OSDI indicated satisfactory equivalence per our study definition (mean difference 1.8, 95% CI –1.4 to 5.0). Moreover, the app-based J-OSDI total score demonstrated good internal consistency and agreement (Cronbach α=...
PMC10436120
Conclusions
This study demonstrated the equivalence of PROs between the app- and paper-based J-OSDI. Implementing the app-based J-OSDI in various scenarios, including telehealth, may have implications for the early diagnosis of DED and longitudinal monitoring of PROs.
PMC10436120
Introduction
Dry eye disease
DISEASE, EYE
Dry eye disease (DED) is the most common disease of the ocular surface, with a prevalence ranging from 5% to 50% [The current diagnostic standards proposed by 2 leading organizations on DED, namely the Tear Film & Ocular Surface Society and the Asian Dry Eye Society, suggest a holistic assessment of patients’ subjectiv...
PMC10436120
Methods
PMC10436120
Study Design and Participants
Parkinson disease, ptosis, mental disease, eyelid disorders
DISEASE, EYELID DISORDER
This prospective, nonblinded, randomized crossover study was conducted at the Department of Ophthalmology at Juntendo University Hospital, Tokyo, Japan. Patients aged ≥20 years were recruited between April 20, 2022, and June 8, 2022. Patients with a history of eyelid disorders, ptosis, mental disease, Parkinson disease...
PMC10436120
Ethics Approval
Written informed consent was obtained from all participants. This study was approved by the Independent Ethics Committee of Juntendo University Faculty of Medicine (E21-0324-H02) and was conducted in accordance with the ethical standards laid down in an appropriate version of the Declaration of Helsinki (as revised in ...
PMC10436120
DryEyeRhythm Smartphone App
DISEASE
The DryEyeRhythm app was developed using the open-source framework ResearchKit (Apple Inc; Screenshots of the DryEyeRhythm app. (A) Screenshot of the DryEyeRhythm test results. (B) Screenshot of the DryEyeRhythm app-based J-OSDI. (C) Screenshot of the DryEyeRhythm measuring menu. J-OSDI: Japanese version of the Ocular ...
PMC10436120
Assessment of Subjective DED Symptoms
Subjective DED symptoms were assessed using the J-OSDI and DEQS questionnaires. The J-OSDI is used for assessing subjective DED symptoms; it is a 12-item instrument with the following 3 subscales: ocular symptoms, vision-related functions, and environmental triggers [The DEQS questionnaire was administered to the parti...
PMC10436120
Clinical Assessment of DED
Meibomian gland dysfunction, CFS
MEIBOMIAN GLAND DYSFUNCTION
We performed DED examinations using the TFBUT, CFS, MBI measurements, the Schirmer test I, and Meibomian gland dysfunction assessment [TFBUT was measured using fluorescein sodium staining (fluorescence ocular examination test paper; Ayumi Pharmaceutical Co) [CFS was evaluated according to the van Bijsterveld grading sy...
PMC10436120
DED Diagnosis
EYE
DED and non-DED were diagnosed using the 2016 Asian Dry Eye Society and Tear Film & Ocular Surface Society Dry Eye Workshop II diagnostic criteria [
PMC10436120
Randomization
The participants were randomized by simple random sampling using the lottery method [
PMC10436120
Statistical Analyses
The sample size was predetermined based on the methodology presented in the Professional Society for Health Economics and Outcomes Research ePRO Good Research Practices Task Force report [The equivalence margin was defined as ±7.0 points from the MCID of the J-OSDI total score [We assessed the internal consistency of t...
PMC10436120
Results
PMC10436120
Internal Consistency and Agreement of the App-Based J-OSDI
Table S1 in
PMC10436120
Discussion
PMC10436120
Principal Findings
In this study, we compared the performance of paper- and app-based J-OSDI through data collected from a DED mHealth app (DryEyeRhythm) to evaluate their equivalency for subjective symptom questionnaires. The app-based J-OSDI total score was comparable to its paper-based counterpart. The recent COVID-19 pandemic limited...
PMC10436120
Limitations
This study had several limitations. First, it may have a selection bias caused by the single-center design at a university hospital in Tokyo, Japan. In addition, most participants were older women. This bias in the target population may have affected the results of J-OSDI item 7. Conversely, the bias observed in the pa...
PMC10436120
Conclusions
Johnson and Johnson Vision
FOUNDER
In conclusion, the app-based J-OSDI and the paper-based J-OSDI were comparable in obtaining data on subjective DED symptoms. Implementing the app-based J-OSDI as a tool for the mHealth management of DED may have implications for the early diagnosis of DED and longitudinal PRO monitoring through an unintrusive collectio...
PMC10436120
Abbreviations
corneal fluorescein stainingdry
DISEASE
corneal fluorescein stainingdry eye diseaseDry Eye-Related Quality-of-Life Scoreelectronic patient-reported outcomeintraclass correlation coefficientJapanese Ocular Surface Disease Indexlimits of agreementmaximum blink intervalminimal clinically important differencemobile healthOcular Surface Disease Indexpatient-repor...
PMC10436120
Data Availability
All data generated or analyzed during this study are included in this published article and its supplementary information files.
PMC10436120
Abstract
PMC10512910
Aims/Introduction
muscle mass
Dapagliflozin is used for individuals with type 1 diabetes, although the effect of this medication on skeletal muscle mass is not well established. In addition, there are few studies examining the effects of good glycemic control on skeletal muscle mass in type 1 diabetes patients. We investigated changes in glycemic c...
PMC10512910
Materials and Methods
appendicular skeletal muscle mass
This was a post‐hoc analysis of a multicenter, open‐label, non‐randomized, prospective, interventional study in individuals with type 1 diabetes. The participants received dapagliflozin at 5 mg/day for 4 weeks, and were reviewed before and after treatment. Weight‐ and height‐corrected appendicular skeletal muscle mass ...
PMC10512910
Results
A total of 36 individuals were included in the analysis. After the 4 weeks of dapagliflozin treatment, ASM/height
PMC10512910
Conclusion
loss of skeletal muscle mass, sarcopenia
SARCOPENIA, LOSS OF SKELETAL MUSCLE MASS
Dapagliflozin treatment of individuals with type 1 diabetes, particularly non‐obese individuals and older men, might result in loss of skeletal muscle mass. However, good glycemic control during treatment might prevent the onset and progression of sarcopenia.Individuals (
PMC10512910
INTRODUCTION
age‐related loss of skeletal muscle mass, sarcopenia, hyperglycemia, fractures, Sarcopenia, muscle mass loss, impaired mobility, diabetes
SARCOPENIA, HYPERGLYCEMIA, SARCOPENIA, TYPE 2 DIABETES, COMPLICATIONS, DIABETES
Sarcopenia is the age‐related loss of skeletal muscle mass and strength, which is associated with impaired mobility, falls and fractures, a decline in activities of daily living, and increased risk of deathThe relationship between glycemic control and sarcopenia in individuals with diabetes has been previously noted. F...
PMC10512910
MATERIALS AND METHODS
PMC10512910
Study design and individuals
We undertook a post‐hoc analysis of a multicenter, open‐label, non‐randomized, prospective, interventional study, which is named as the RISING‐STAR study
PMC10512910
Measurement
BLOOD
Blood tests were carried out at the baseline and at week 4 (referring to the last observation day, 4 weeks after the intervention) to measure blood glucose and HbA1c. BMI and body composition were measured using Inbody 720 (InBody Co., Ltd., Seoul, Korea), a non‐invasive body composition analyzer, at the baseline and a...
PMC10512910
Statistical analysis
Baseline characteristics were summarized as frequency (%) for categorical variables and as mean ± standard deviation (SD) for continuous variables. The associations between baseline skeletal muscle mass and other measured variables were examined using unpaired
PMC10512910
RESULTS
appendicular skeletal muscle mass, Appendicular skeletal muscle mass, skeletal muscle mass
HEMOGLOBIN; S
The changes of skeletal muscle mass for 4 weeks of dapagliflozin combination therapy were evaluated in 36 participants with type 1 diabetes (12 men and 24 women; Table Summary characteristics of the study cohortData are expressed as frequencies (percentages) for categorical variables or mean (standard deviation) for co...
PMC10512910
DISCUSSION
skeletal muscle mass
ASM / heightWe found that ASM / heightThe present study shows that SGLT2i administration might have an unfavorable effect on skeletal muscle mass in older men with type 1 diabetes. It is widely known that the absolute amount of skeletal muscle mass is higher in men than in womenGood glycemic control in individuals with...
PMC10512910
DISCLOSURE
MH, Johnson & Johnson K.K., CRB
MH received grants from AstraZeneca K.K., Ono Pharma Co. Ltd. and Kowa Pharma Co. Ltd., and received personal fees from AstraZeneca K.K., Ono Pharma Co. Ltd., Eli Lilly, Japan, Sumitomo Dainippon Pharma Co., Ltd., Daiichi Sankyo Co. Ltd., Mitsubishi Tanabe Pharma Corp., Sanofi K.K., K.K. and Kowa Pharma Co. Ltd. outsid...
PMC10512910
DATA AVAILABLITY STATEMENT
The data used in this study and the datasets analyzed are available from the corresponding author upon request.
PMC10512910
ACKNOWLEDGMENTS
The RISING‐STAR study is funded by AstraZeneca K.K. and Ono Pharmaceutical Co., Ltd. No drugs were donated or funded by the sponsor. The funding bodies had no role in the study design, data collection and analysis, decision to publish or preparation of the manuscript. The authors thank all the clinical staff for their ...
PMC10512910
REFERENCES
PMC10512910
Purpose
lymphedema, MLD, pain
LYMPHEDEMA, MLD, SOFT TISSUE SWELLING, POSTOPERATIVE COMPLICATIONS
Postoperative soft tissue swelling is a significant factor influencing outcomes after elbow surgery. It can crucially affect important parameters such as postoperative mobilization, pain, and subsequently the range of motion (ROM) of the affected limb. Furthermore, lymphedema is considered a significant risk factor for...
PMC10491702
Methods
pain
SECONDARY, MLD
A total of 50 consecutive patients undergoing elbow surgery were enrolled. The patients were randomized into 2 groups. 25 participants per group were either treated by conventional MLD or NP. The primary outcome parameter was defined as the circumference of the affected limb in cm postoperative up to seven days postope...
PMC10491702
Results and conclusion
MLD, swelling, pain
MLD
NP showed an overall equivalent influence compared to MLD in reducing upper limb swelling after surgery. Moreover, the application of NP showed a significant decrease in overall pain perception compared to manual lymphatic drainage on days 2, 4 and 5 after surgery (
PMC10491702
Conclusion
postoperative swelling
Our findings show that NP could be a useful supplementary device in clinical routine treating postoperative swelling after elbow surgery. Its application is easy, effective and comfortable for the patient. Especially due to the shortage of healthcare workers and physical therapists, there is a need for supportive measu...
PMC10491702
Keywords
Open Access funding enabled and organized by Projekt DEAL.
PMC10491702
Introduction
postoperative pain, MLD, swelling, posttraumatic, pain, fractures, postoperative lymphedema
MLD, COMPLICATIONS, DISORDERS
Surgical treatment of elbow pathologies remains challenging as they are heterogenous and the spectrum of patient´s age and individual physical demand is wide-ranging. Common indications for surgical therapy arise from fractures and posttraumatic conditions but also from other disorders associated with pain, stiffness o...
PMC10491702
Materials and methods
PMC10491702
Study cohort
MLD
A total of 50 consecutive patients who underwent elbow surgery were enrolled prospectively. They were divided into two independent groups of 25 patients each by blinded randomization. Each group was either treated by conventional MLD or NP via a technical device (
PMC10491702
Inclusion criteria
infection, triad injuries, fractures, distal humerus fractures
INFECTION
Patients more than 18 years old with written informed consent undergoing inpatient stay after elbow surgery were included.The extent of elbow surgery required hat to be a major procedure requiring an expected postoperative stay of at least 3 days. This included primary implantation of an elbow prosthesis, re-implantati...
PMC10491702
Exclusion criteria
peri-implant
DEEP VEIN THROMBOSIS (DVT), DISORDERS, ACUTE INFECTION, JOINT INFECTION, LYMPHEDEMA
Exclusion criteria were defined as follows: Acute infection of the upper extremity including wound healing disorders and peri-implant or peri-prosthetic joint infection, chronic or acute history of deep vein thrombosis (DVT), chronic or acute history of lymphedema. Patient´s withdrawal from the study was possible at an...
PMC10491702
Data collection
Pain, pain
SECONDARY
Medical data were collected and stored electronically. Pseudonymization was strictly ensured. Primary outcome parameters were defined as the circumference of the affected limb in cm after surgery, secondary outcome parameters were defined as follows: Subjective perception of pain (measured via visual analogue scale, VA...
PMC10491702
Treatment groups—MLD vs. NP
lymphedema, MLD
LYMPHEDEMA, MLD
Treatment of lymphedema started on the first postoperative day after surgery. Either MLD or NP was performed on patients respectively.When performing MLD, the therapist started activation of lymphatic tissue around the neck, with the torso and the affected limb following. Using special grip techniques according to the ...
PMC10491702
Adverse events
thrombosis, death
DISORDER, ADVERSE EVENT, WOUND INFECTION, THROMBOSIS
Adverse events were defined as wound infection, wound healing disorder, thrombosis of the affected extremity and death.
PMC10491702
Statistical analysis
To calculate the required sample size a power analysis was performed with an estimated mean difference of two ± two cm (circumferential difference of the affected limb) between groups. For a power of 0.95 the analysis resulted in 24 patients for each group. We enrolled 25 patients in each group. Student’s Student’s
PMC10491702
Ethics
All procedures performed in our study involving patients were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Institutional ethics committee approval was given prior to this study (19–1457).
PMC10491702
Clinical trial number
The study is registered in the responsible National Clinical Trials Register (DRKS00018822).
PMC10491702
Results
PMC10491702
Treatment-associated outcomes—postoperative swelling
swelling
MLD
We witnessed a generalized increase in the circumference of the affected limb postoperatively. The maximum swelling in the NP group was present within the first 2 days after surgery whereby it showed that the landmarks of the elbow joint, ten cm below it and around the wrist were the most affected localizations of swel...
PMC10491702
Perception of pain
pain
MLD
The mean preoperative pain level in the MLD group was 2.2 compared to 2.9 in the NP group (VAS measured at day zero (preoperative) till day six: Statistically significant differences (*) between the subgroups were found on days one, two, four and five. The horizontal line in the middle of each box indicates the median;...
PMC10491702
Adverse events
ADVERSE EVENTS
Both treatment groups showed no adverse events during the observation period.
PMC10491702
Discussion
postoperative swelling, MLD, swelling, inflammation, heterotopic-ossification, pain, trauma
ADVERSE EVENTS, INFLAMMATION, MLD, LYMPHEDEMA, PATHOLOGY
In this prospective randomized controlled trial, we compared the effect of a technical device based on negative pressure application to manual lymphatic drainage in the context of postoperative swelling after elbow surgery in 50 consecutive patients.The elbow joint is considered particularly important in every activity...
PMC10491702
Conclusions
MLD, swelling, postoperative swelling and, pain, postoperative lymphedema
MLD
This RCT investigated the effect of NP and MLD on postoperative limb swelling and its associated consequences after elbow surgery. NP showed an equivalent reduction in limb swelling compared to MLD. In fact, patients' subjective postoperative perception of pain tended to be lower in the NP group after 4 days. To conclu...
PMC10491702
Author contribution
All authors contributed to the study's conception and design. Material preparation, data collection and analysis were performed by AH. The first draft of the manuscript was written by AH and MW. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
PMC10491702
Funding
Open Access funding enabled and organized by Projekt DEAL. There is no funding source.
PMC10491702
Declarations
PMC10491702
Conflict of interest
The authors, their immediate family, and any research foundation with which they are affiliated did not receive any financial payments or other benefits from any commercial entity related to the subject of this article.
PMC10491702
Ethical approval
Institutional ethics committee approval was given prior to this study (19–1457).
PMC10491702
Informed consent
Informed consent was obtained from all individual participants included in the study.
PMC10491702
References
PMC10491702
Objectives
URETHRAL STRICTURE, COLD
To report the safety and efficacy of holmium laser and compare its results with cold knife visual internal urethrotomy (VIU) in the management of short segment urethral stricture.
PMC10352168
Methods
URETHRAL STRICTURES, STRICTURE, COLD, COLD
This prospective randomized study included 66 male patients aged more than 18 years, with short segment bulbar urethral strictures < 2 cm from March 2020 to March 2022. The patients were randomized into two groups each containing 33 patients. In group A (Cold knife group), Sachse cold knife was used for stricture treat...
PMC10352168
Results
RECURRENCE, COLD, COMPLICATION
There was significant improvement in the mean values of IPSS, PVR and Qmax in both groups. There was no significant difference between both groups in the mean values of IPSS, PVR and Qmax during follow-up visits. However, at the end of follow-up at one year there was statistically significant difference between both gr...
PMC10352168