#22927

A Randomized Controlled Trial Evaluating the Optilume Urethral Drug Coated Balloon vs Endoscopic Management for Treatment of Recurrent Anterior Urethral Strictures
Chee J1, Elliott S2, Virasoro R3, DeLong J3, Coutinho K4, Robertson K5, D'Anna R6
1. MURAC Health, 2. University of Minnesota, Minneapolis, 3. Eastern Virginia Medical School, Norfolk, 4. New Jersey Urology, Millburn, 5. Chesapeake Urology Research Associates, Hanover, 6. Arkansas Urology Research Center, Little Rock
KEYWORDS: New Devices, Prospective Study, Male
Current endoscopic management of anterior urethral strictures includes mechanical dilation or direct visualization internal urethrotomy (DVIU), however long-term success rates are in the range of 35-70% for primary treatment. Multiple endoscopic treatments of the same stricture lead to progressively worse outcomes. The Optilume® Urethral Drug Coated Balloon (DCB) is a urethral dilation balloon with a proprietary paclitaxel coating that combines mechanical dilation of the stricture for immediate symptomatic relief with local drug delivery to maintain urethral patency. ROBUST III is a prospective, multicenter, randomized, controlled single-blind trial to evaluate the safety and efficacy of the Optilume DCB against standard of care endoscopic management of recurrent anterior urethral strictures.