Optilume Registry for Treatment of Stricture of the Anterior Urethra

Anterior Urethral Stricture, Male Clinical Trial

Official title: European Clinical Registry for Optilume Urethral Drug Coated Balloon

Status Recruiting

Clinical Trial Summary

The purpose of this registry is verifying the continued safety and effectiveness of the Optilume DCB clinical use in patients undergoing dilation of the urethral stricture.

Clinical Trial Description

After being informed about the registry and potential risks, all patients providing written informed consent will undergo urethral dilation using the Optilume Drug Coated Balloon (standard of care procedure). At 3, 6, 12 months, and annually 2 to 5 years after treatment patients will be invited to return to the hospital and several assessments will be performed, including questionnaires, if this is part of their standard care. ;

Related Conditions & MeSH terms

• Anterior Urethral Stricture, Male
• Constriction, Pathologic
• Urethral Stricture

• NCT number: NCT05479422
• Study type: Observational [Patient Registry]
• Source: European Association of Urology Research Foundation
• Contact: Wim Witjes, MD
• Phone: +31 26 389 0677
• Email: w.witjes@uroweb.org
• Status: Recruiting
• Start date: October 13, 2022
• Completion date: August 15, 2029