Status:
RECRUITING
A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)
Lead Sponsor:
UroMems SAS
Conditions:
Stress Urinary Incontinence (SUI)
Eligibility:
MALE
22+ years
Phase:
NA
Brief Summary
Prospective, multicenter, single-arm study
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
May 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06968741
Start Date
May 19 2025
End Date
December 1 2031
Last Update
September 10 2025
Active Locations (1)
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1
Groupe Hospitalier Pitié-Salpêtrière
Paris, France