Study Comparing Paclitaxel-Coated Balloon and Non-Coated Balloon for Treating Recurrent Urethral Strictures A Randomized Multicenter Trial in Adults Eligible for Open Urethroplasty

What this Trial Is About

This research aims to evaluate whether a paclitaxel-coated dilatation balloon called Optilume can improve treatment outcomes for people with recurrent urethral strictures after previous endoscopic treatments such as dilatation or direct visual internal urethrotomy DVIU. Urethral strictures are narrowings of the urethra that often require intervention, and while open urethroplasty has a higher success rate, it carries more risks and requires general anesthesia. This study focuses on patients who might otherwise be candidates for open urethroplasty due to recurrence after less invasive procedures. Participants will be randomly assigned to receive either dilatation using the paclitaxel-coated balloon Optilume or a non-coated balloon UroMax Ultra to treat their urethral stricture. Both treatments involve the use of a balloon device to widen the narrowed urethra. The study compares these two methods to see if the drug coating can reduce the chance of stricture recurrence and the need for further interventions or surgery. The trial is a prospective, randomized, multicenter study with a Phase 4 designation. During the study, participants will be followed for up to 18 months after treatment to track outcomes such as functional and anatomical recurrence of the stricture, urine flow rate Qmax, time to urinate, and urethral stricture scores at multiple time points. Researchers will collect these measurements at 6, 12, and 18 months to assess the effectiveness of the interventions. The study excludes patients with certain conditions such as complete strictures without any lumen, previous radiation therapy, or previous open urethroplasty. Participants must be able to provide informed consent and be eligible for open urethroplasty.

Risk of Recurrent Urethral Stricture After Treatment With Paclitaxel-Coated Dilatation Balloon (Optilume) Compared With Non-coated Dilatation Balloon