Active — Not RecruitingNot Applicable

Optilume Registry for Treatment of Stricture of the Anterior Urethra

Belgium, Italy, Norway150 participantsStarted 2022-10-13

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. Male subjects ≥ 18 years old
✓. 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.
✓. Subject provides written informed consent using an approved Informed Consent Form (ICF) and is willing to comply with standard follow-up assessments.

Exclusion criteria

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

What they're measuring

Responder Rate at 12 Months

Timeframe: 12 months

Rate of Treatment Related Serious Adverse Events at 3 months

Timeframe: 3 months

Trial details

NCT IDNCT05479422

SponsorEuropean Association of Urology Research Foundation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-08-15

View on ClinicalTrials.gov More Anterior Urethral Stricture, Male trials