Optilume Registry for Treatment of Stricture of the Anterior Urethra

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-13

Study Completion Date

2029-08-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anterior Urethral Stricture, Male

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment of stricture of the anterior urethra with optilume DCB

Standard of care treatment of stricture of the anterior urethra using the Optilume Drug Coated Balloon.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No