Clinical Trial: Treatment of Bulbar Urethral Strictures With Optilume Drug-Coated Balloons in an Untreated Population

U.S., Feb. 15 -- ClinicalTrials.gov registry received information related to the study (NCT06827210) titled 'Treatment of Bulbar Urethral Strictures With Optilume Drug-Coated Balloons in an Untreated Population' on Jan. 30.

Brief Summary: This randomized controlled trial investigates the effectiveness and safety of the Optilume(R) drug-coated balloon (DCB) compared to standard direct visual internal urethrotomy (DVIU) in the treatment of bulbar urethral strictures. The primary objective is to assess freedom from repeat intervention at 12 months. Secondary objectives include evaluating urethral patency, urinary symptoms, and sexual function through objective measures (Qmax, PVR, cystoscopy) and patient-reported outcomes (USS-PROM, IPSS, IIE...