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Treatment of Bulbar Urethral Strictures With Optilume Drug-Coated Balloons in an Untreated Population
Sponsor: Aalborg University Hospital
Summary
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.
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2025-02-07
Completion Date
2027-07
Last Updated
2025-02-14
Healthy Volunteers
No
Conditions
Interventions
Optilume DCB
Optilume DCB is a drug-coated balloon catheter designed for the treatment of bulbar urethral strictures. It combines mechanical dilation with localized drug delivery to reduce stricture recurrence and promote urethral healing. The balloon is coated with paclitaxel, an antiproliferative agent, to minimize scar tissue formation and improve treatment outcomes.
Standard Direct Visual Internal Urethrotomy (DVIU)
Standard Direct Visual Internal Urethrotomy (DVIU), also known as Sachse Internal Urethrotomy, is a minimally invasive endoscopic procedure for treating urethral strictures.
Locations (3)
Gødstrup Regional Hospital
Gødstrup, Central Jutland, Denmark
Aalborg University Hospital
Aalborg, Region North Jutland, Denmark
North Denmark Regional Hospital
Hjørring, Region North Jutland, Denmark