Clinical Study to Assess Semen Quality and Safety After Treatment of Urethral Stricture with the Optilume Drug Coated Balloon in Men Aged 22 to 65

What this Trial Is About

This research evaluates semen quality after treatment with the Optilume Urethral Drug Coated Balloon DCB in men aged 22 to 65 who have an anterior urethral stricture treatable with this device. It is a single-arm, prospective study involving 34 male participants across multiple sites in the United States. The study aims to assess various urinary and sexual function outcomes following treatment. Participants receive the Optilume Urethral DCB, a catheter with a balloon coated with the drug paclitaxel that transfers the medication to the urethral wall upon inflation. The study includes follow-up visits at 30 days, 3 months, 6 months, and 12 months after treatment to monitor symptoms and function. Semen quality is tested before treatment and at 3 and 6 months post-treatment, with additional testing up to 12 months if abnormalities are detected. During the study, participants undergo evaluations of urinary symptoms, sexual function, and voiding function at scheduled intervals. Semen samples are collected to assess sperm characteristics. Safety endpoints are reviewed at 3 and 6 months. Follow-up continues for up to a year or longer if semen abnormalities persist, ensuring comprehensive monitoring of treatment effects and participant well-being.

Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters