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Optilume Registry for Treatment of Stricture of the Anterior Urethra | Clinical Trials | Clareo Health

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Optilume Registry for Treatment of Stricture of the Anterior Urethra

European Clinical Registry for Optilume Urethral Drug Coated Balloon

NCT05479422•European Association of Urology Research Foundation

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.

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Male subjects ≥ 18 years old
•2. Subject diagnosed with a recurrent stricture ≤3cm in the anterior urethra that plans to be treated with Optilume® DCB in accordance with the approved Instructions for Use.
•3. Subject provides written informed consent using an approved Informed Consent Form (ICF) and is willing to comply with standard follow-up assessments.

Exclusion Criteria

•1. Subjects with a known hypersensitivity to paclitaxel or structurally related compounds.
•2. Subject is unwilling to abstain or use a condom for 30 days after the procedure.
•3. Subject is unwilling to use highly effective contraception for 6 months after the procedure if partner is of childbearing potential.
•4. Subjects with a history of carcinoma of the genitourinary system (e.g., kidney, bladder, prostate, urethra, testes) that is not considered in complete remission.

Locations (13)

AZ Middelares

Ghent, Belgium

Department of Urology - San Raffaele University

Milan, Italy

AOU "Città della Salute e della Scienza" University of Turin

Torino, Italy

AOUI Verona, Urology Unit

Verona, Italy

Oslo university hospital Rikshospitalet

Oslo, Norway

Marques de Valdecilla University Hospital

Santander, Cantabria, Spain

Lyx I Instituto de Urología

Madrid, Spain

Hospital Universitario de Navarra

Pamplona, Spain

Epsom and St Helier Hospitals

Carshalton, United Kingdom

Frimley Park Hospital, Frimley Health NHS Foundation Trust

Frimley, United Kingdom

Key Dates

Start Date

October 13, 2022

Primary Completion Date

August 15, 2029

Completion Date

August 15, 2029

Last Updated

February 24, 2025

Enrollment

150

ESTIMATED participants

Conditions

Anterior Urethral Stricture, Male

Pre-operative Assessment by Sonourethrography Only in Anterior Urethral Strictures.

NCT04452890

Anterior Urethral Stricture, Male

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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