Pilot Study Comparing Timing of Graft Use in Multi-stage Male Urethroplasty Using Dorsal Graft Inlay Technique for Penile Urethral Stricture

What this Trial Is About

Urethral stricture disease affects the male urethra and can be treated with urethroplasty, a reconstructive surgery to restore urethral opening. This research compares two multi-stage urethroplasty approaches using a dorsal graft inlay technique, either applied in the first or second surgery stage. The study aims to assess failure rates after one year of follow-up to guide future larger trials. The trial involves two groups one receiving the graft during the first stage where the urethra is opened and graft inserted, followed later by retubularization the other group has the graft applied in the second stage after initial urethral opening. Both use oral mucosa grafts. The study also evaluates additional outcomes such as complications, erectile and ejaculatory function, urinary symptoms, continence, quality of life, patient satisfaction, and urine flow rates at various times before and after surgeries. Participants are adult males with isolated penile urethral strictures needing multi-stage repair with graft. They will have follow-up assessments including clinical evaluations and questionnaires at pre-surgery, 3 months after first stage, 3 months after second stage, and one year post-second stage. The main result is the graft failure rate after one year. Safety and feasibility of randomization are monitored. Total participation lasts at least one year after the second surgery.

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