Urethral Stricture, Anterior

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Review clinical trials related to Urethral Stricture, Anterior. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

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

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.

Participants needed: 140
Trial details
Age: 18+Biological sex: MaleType: InterventionalSponsor: Aalborg University HospitalUpdated: Feb 14, 2025Locations: 3
Eligibility criteria

Male patients aged 18 years or older. [+4]

Female (chromosomal) sex. [+8]