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

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.

Conditions

• Urethral Stricture
• Urethral Stricture, Anterior
• Urethral Stricture, Male
• Urethral Stricture Less Than 2 cm

Interventions

DEVICE

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.

PROCEDURE

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.

Sponsors & Collaborators

• Gødstrup Hospital

  collaborator OTHER

• Regionshospital Nordjylland

  collaborator OTHER_GOV

• Aalborg University Hospital

  lead OTHER

Principal Investigators

• Tommy K Nielsen, MD, PHD · Aalborg University Hospital

• Marco B Mahdi, MD · Aalborg University Hopsital

• Henrik Weinreich, MD · Regionshospital Nordjylland

• Charlotte H Graugaard-Jensen, MD, PHD · Gødstrup Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-07

Primary Completion

2027-01-31

Completion

2027-07-31

FDA Device

Yes

Countries

• Denmark

Study Locations