Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter In the treAtment of Stress Urinary Incontinence in Men
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Prospective, multicenter, single-arm study
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 22
Healthy Volunteers: f
View:
• 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
Locations
United States
California
University of California, Los Angeles
RECRUITING
Los Angeles
University of California, San Francisco
RECRUITING
San Francisco
Stanford University
RECRUITING
Stanford
Minnesota
Minnesota Urology
RECRUITING
Bloomington
Mayo Clinic
RECRUITING
Rochester
North Carolina
Wake Forest University of Health Sciences
RECRUITING
Charlotte
Duke University
RECRUITING
Durham
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
University of Texas, Southwestern
RECRUITING
Dallas
Urology Clinics of North Texas
RECRUITING
Dallas
University of Texas, MD Anderson
RECRUITING
Houston
Virginia
Urology of Virginia
RECRUITING
Virginia Beach
Other Locations
France
Centre Hospitalier Universitaire de Lille
RECRUITING
Lille
Hospitals Academics De Marseille Conception
RECRUITING
Marseille
Centre Hospitalier Universitaire de Nantes
RECRUITING
Nantes
Groupe Hospitalier Pitié-Salpêtrière
RECRUITING
Paris
Centre Hospitalier Univeritaire de Lyon - Hôpital Lyon Sud
RECRUITING
Pierre-bénite
Centre Hospitalier Universitaire de Rennes
RECRUITING
Rennes
Centre Hospitalier Universitaire de Rouen
RECRUITING
Rouen
Hopital Foch
RECRUITING
Suresnes
Contact Information
Primary
Roshini Jain
roshini.jain@uromems.com
14697669888
Time Frame
Start Date: 2025-05-19
Estimated Completion Date: 2031-12
Participants
Target number of participants: 140
Treatments
Experimental: UroActive AUS Implant
Enrolled subjects who meet study eligibility criteria will proceed to receive the UroActive Artificial Urinary Sphincter (AUS) device
Related Therapeutic Areas
Sponsors
Leads: UroMems SAS