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

Launched by AALBORG UNIVERSITY HOSPITAL · Feb 13, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option for men with bulbar urethral strictures, which are narrowings in the urethra that can cause urinary issues. The study is comparing a special drug-coated balloon called Optilume® to the standard procedure known as direct visual internal urethrotomy (DVIU). The main goal is to see how effective the Optilume balloon is in preventing the need for further treatments within a year. Researchers will also look at how well the urethra is working, any urinary symptoms, and how sexual function is affected through both tests and patient feedback.

To participate in this trial, men aged 18 and older who have never been treated for a single bulbar urethral stricture less than 3 cm long may be eligible. Participants will be closely monitored for 6 and 12 months after treatment. It’s important to note that individuals with certain medical histories or conditions, such as previous urethra treatments or specific allergies, will not be able to join the study. This trial aims to provide valuable information about the safety and effectiveness of the Optilume balloon as a potential alternative treatment.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • Able to provide written informed consent.
• Exclusion Criteria:
• • Female (chromosomal) sex.
• • History of prior urethral stricture or prior treatment thereof.
• • History of hypospadias repair.
• • History of genital lichen sclerosis.
• • Active or unresolved confounding etiology, including bladder neck contracture, neurogenic bladder, known or being evaluated for symptomatic benign prostatic hyperplasia (BPH) or surgical treatment for BPH within the last 5 years.
• • Known allergy or hypersensitivity to paclitaxel or any component of the Optilume DCB.
• • Known peripheral artery disease.
• • Severe comorbidities with an American Society of Anesthesiologists (ASA) score of 4 or higher.
• • Patients unable to comply with follow-up protocols or provide informed consent.