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

Study acronym: FIRST-CARE
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
This randomized controlled trial investigates the effectiveness and safety of the Optilume® 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, IIEF-5). The study will recruit 140 participants across multiple sites, with follow-ups conducted at 6 and 12 months. This trial seeks to provide evidence for Optilume DCB as a safe and effective alternative to standard treatment.
Trial Details
NCT Number NCT06827210
Lead Sponsor Aalborg University Hospital
Collaborators: Gødstrup Hospital, Regionshospital Nordjylland
Conditions
(from sponsor)		 Urethral Stricture, Urethral Stricture, Anterior, Urethral Stricture, Male, Urethral Stricture Less Than 2 cm
Related terms Urethral Stricture
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov