Optilume Registry for Treatment of Stricture of the Anterior Urethra

European Clinical Registry for Optilume Urethral Drug Coated Balloon

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.

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.

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.