Study detail
RecruitingObservational
Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter In the treAtment of Stress Urinary Incontinence in Men
UroMems SAS
Summary
Prospective, multicenter, single-arm study
Eligibility
- Age range
- 22+ years
- Sex
- Male
- Healthy volunteers
- No
Detailed 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…
Interventions
- DeviceArtificial Urinary Sphincter (AUS)
AUS implant
Locations (21)
- University of California, Los AngelesLos Angeles, California
- University of California, San FranciscoSan Francisco, California
- Stanford UniversityStanford, California
- Minnesota UrologyBloomington, Minnesota
- Mayo ClinicRochester, Minnesota
- Wake Forest University of Health SciencesCharlotte, North Carolina