A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)

Part of paid clinical trials in Los Angeles, California.

Sponsor: UroMems SAS
Study ID: NCT06968741
Status: Recruiting

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Conditions

Stress Urinary Incontinence (SUI)

Eligibility Criteria

Sex: MALE
Age: 22 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Artificial Urinary Sphincter (AUS) — DEVICE
AUS implant

Study Details

Prospective, multicenter, single-arm study

Key Dates

Start date: May 19, 2025
Status verified: Mar 2026
Primary completion: Dec 31, 2026
Completion: Dec 31, 2031

Study Design

Enrollment: 140 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: UroActive AUS Implant
Enrolled subjects who meet study eligibility criteria will proceed to receive the UroActive Artificial Urinary Sphincter (AUS) device

Primary Outcome Measure

Responder rate at 26 weeks post-activation [ Time Frame: 26 weeks ]

Central Contacts

Roshini Jain
14697669888
[email protected]

Locations (13)

Facility	City	State	ZIP	Site coordinators
University of California, Los Angeles	Los Angeles	California	90095	Victor Nitti, MD [email protected]
University of California, San Francisco	San Francisco	California	94153	Benjamin Breyer, MD [email protected]
Stanford University	Stanford	California	94305	Craig Comiter, MD [email protected]
Minnesota Urology	Bloomington	Minnesota	55420	Michael Ehlert, MD [email protected]
Mayo Clinic	Rochester	Minnesota	55950	Daniel Elliott, MD [email protected]
Wake Forest University of Health Sciences	Charlotte	North Carolina	28204	Michael Kennelly, MD [email protected]
Duke University	Durham	North Carolina	27710	Andrew Peterson, MD [email protected]
Cleveland Clinic Foundation	Cleveland	Ohio	44106	Kenneth Angermeier, MD [email protected]
Vanderbilt University Medical Center	Nashville	Tennessee	37232	Melissa Kaufman, MD [email protected]
University of Texas, Southwestern	Dallas	Texas	75390	Steven Hudak, MD [email protected]
Urology Clinics of North Texas	Dallas	Texas	75231	Allen Morey, MD [email protected]
University of Texas, MD Anderson	Houston	Texas	77030	Lenaine Westney, MD [email protected]
Urology of Virginia	Virginia Beach	Virginia	23462	Kurt McCammon, MD [email protected]

Find similar trials in Los Angeles, CA

By research site

University of California, Los Angeles· Los Angeles, CA University of California, San Francisco· San Francisco, CA Stanford University· Stanford, CA Minnesota Urology· Bloomington, MN Mayo Clinic· Rochester, MN Wake Forest University of Health Sciences· Charlotte, NC

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