A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)
Purpose
Prospective, multicenter, single-arm study
Condition
- Stress Urinary Incontinence (SUI)
Eligibility
- Eligible Ages
- Over 22 Years
- Eligible Sex
- Male
- Accepts Healthy Volunteers
- No
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
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental UroActive AUS Implant |
Enrolled subjects who meet study eligibility criteria will proceed to receive the UroActive Artificial Urinary Sphincter (AUS) device |
|
Recruiting Locations
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- UroMems SAS