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 location...
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
Other Locations
France
Groupe Hospitalier Pitié-Salpêtrière
RECRUITING
Paris
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