Multi-stage Urethroplasty with Augmentation Using a Dorsal Graft Inlay Technique Comparing Graft Use in First or Second Stage

Launched by UNIVERSITY HOSPITAL, GHENT · Jul 6, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a surgical technique called multi-stage urethroplasty, which is used to treat urethral stricture, a condition where the urethra (the tube that carries urine from the bladder) becomes narrowed. The researchers want to compare two different ways of using a graft (a piece of tissue) during the surgery to see which method has a lower chance of failure after one year. This initial study will help them design a larger trial in the future.

To participate in this trial, you must be a male adult, at least 18 years old, and fit for surgery. You should have a specific type of urethral stricture that requires this multi-stage procedure using a graft made from oral mucosa (the lining inside your mouth). If you decide to join, you will undergo surgery and be followed up for a year to monitor your recovery and the success of the treatment. It's important to note that some individuals might be excluded if they have certain conditions or if the surgeon decides during the procedure that a different approach is necessary.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations.
• • Age ≥ 18 years.
• • Male patient.
• • Fit for operation, upon surgeon's discretion.
• • Isolated penile stricture that requires a multi-stage urethroplasty with dorsal inlay of a graft (upon surgeon's discretion).
• • Use of oral mucosa as graft material.
• • Patient is able and willing to comply with protocol.
• • Prior urethral surgery (dilation, urethrotomy of urethroplasty) is allowed.
• Exclusion Criteria:
• • Absence of signed written informed consent.
• • Age \< 18 years.
• • Female patients.
• • Transgender patients.
• • Patients unfit for operation.
• • Stricture disease extending beyond the penile urethra or concomitant stricture at a different urethral segment.
• • Use of graft other than oral mucosa.
• • Any condition or situation, which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study.
• • Unwilling or unable to comply with study protocol.
• • Patients deciding not to undergo the second stage will be excluded post-hoc.
• • When the surgeon intra-operatively decides to carry out a single-stage procedure after all, the patient will also be excluded post-hoc.
• • If the surgeon decides that no graft is needed to retubularize the urethra, the patient will also be excluded post-hoc.
• • If the surgeon decides that a two-stage Bracka repair is needed, where the urethral plate is entirely cut away during the first stage and grafted, the patient will also be excluded post-hoc.