A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)
Not Applicable
Recruiting
- Conditions
- Stress Urinary Incontinence (SUI)
- Registration Number
- NCT06968741
- Lead Sponsor
- UroMems SAS
- Brief Summary
Prospective, multicenter, single-arm study
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 140
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Responder rate at 26 weeks post-activation 26 weeks Proportion of subjects who report greater than or equal to 50% reduction in the 24 hour Pad Weight Test (PWT) at 26 weeks compared with Baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Groupe Hospitalier Pitié-Salpêtrière
🇫🇷Paris, France
Groupe Hospitalier Pitié-Salpêtrière🇫🇷Paris, FranceEmmanuel Chartier-KastlerContactemmanuel.chartier-kastler@aphp.fr