Clinical Research Directory

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1 clinical study listed.

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Urethral Stricture Less Than 2 cm

Tundra lists 1 Urethral Stricture Less Than 2 cm clinical trial. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.

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NOT YET RECRUITING

NCT06827210

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.

Gender: MALE

Ages: 18 Years - Any

Updated: 2025-02-14

2 states

Urethral Stricture

Urethral Stricture, Anterior

Urethral Stricture, Male