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.
Male patients aged 18 years or older.
Diagnosed with a treatment-naive, single bulbar urethral stricture.
Stricture length ≤3 cm.
Eligible for local treatment with paclitaxel.
Female (chromosomal) sex.
History of prior urethral stricture or prior treatment thereof.
History of hypospadias repair.
History of genital lichen sclerosis.
Aalborg University Hospital
Lead sponsor
Gødstrup Hospital
Collaborator
Regionshospital Nordjylland
Collaborator