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ClinicalTrials.gov ID

NCT06968741

Lead Sponsor

UroMems SASINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

140Estimated

Last Update Posted

Mar 27, 2026Actual

Start Date

May 19, 2025Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2031Estimated

Official Title

Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter In the treAtment of Stress Urinary Incontinence in Men

Brief Summary

Prospective, multicenter, single-arm study

• Stress Urinary Incontinence (SUI)

• Artificial Urinary Sphincter (AUS)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Male

Accepts Healthy Volunteers

No

Eligibility Criteria

Key Inclusion Criteria:

• Male subjects aged ≥ 22 years old
• Able to read, comprehend and willing to sign an informed consent form
• Primary diagnosis of stress urinary incontinence for at least 6 months, as assessed by the investigator
• Appropriate surgical candidate with no medical or mental condition that would interfere with study procedures or confound study outcomes as assessed by the investigator

Key Exclusion Criteria:

• Currently enrolled or plans to enroll in another investigational device or clinical drug trial or has completed an investigational study (for urinary incontinence) in the past 3 months prior to informed consent
• Poor candidate for surgical procedures and/or anesthesia, as determined by investigator
• Currently implanted with an Active Implantable Medical Device (AIMD)
• Symptoms or diagnosis of urge incontinence or mixed incontinence (MI) with a predominant urgency component, as assessed by the investigator

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

UroMems SASINDUSTRY

a.vidart@hopital-foch.com