Actively Recruiting
Study to Assess the Safety and Effectiveness of the UrOActive4 Artificial Urinary Sphincter In the Treatment of Stress Urinary Incontinence in Men
Led by UroMems SAS · Updated on 2026-03-27
140
Participants Needed
21
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the safety and effectiveness of the UrOActive4 Artificial Urinary Sphincter (AUS) device in men diagnosed with stress urinary incontinence (SUI). It is a prospective, multicenter, single-arm clinical study focused on evaluating this device in appropriate surgical candidates. The study is sponsored by UroMems SAS and targets adult men aged 22 years or older who have experienced SUI for at least six months. Participants who meet the eligibility requirements will receive the UroActive AUS implant during the study. The treatment involves surgically implanting the device, which is designed to manage stress urinary incontinence symptoms. There are no comparator groups as this is a single-arm study. The trial focuses on monitoring the safety and effectiveness of the device over time. During the study, participants will be assessed for their response to the implant, with a key measurement being the responder rate at 26 weeks after the device activation. Researchers will evaluate outcomes related to urinary control and any potential safety concerns. The study will continue through 2031, providing long-term observation of participants' progress following the implantation.
CONDITIONS
Brief Title
A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subjects aged 2 years or older
- Able to read, comprehend, and willing to sign an informed consent form
- Primary diagnosis of stress urinary incontinence for at least 6 months
- Appropriate surgical candidate with no medical or mental conditions interfering with study procedures or outcomes
You will not qualify if you...
- Currently enrolled or planning to enroll in another investigational device or drug trial for urinary incontinence or completed one in the past 3 months
- Poor candidate for surgery or anesthesia
- Currently implanted with an Active Implantable Medical Device (AIMD)
- Symptoms or diagnosis of urge incontinence or mixed incontinence with a predominant urgency component
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 26 weeks post-activation
Participants receive the UrOActive Artificial Urinary Sphincter (AUS) implant.
1 surgical implantation visit and multiple follow-up visits up to 26 weeks
Trial Site Locations
Total: 21 locations
1
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
2
University of California, San Francisco
San Francisco, California, United States, 94153
Actively Recruiting
3
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
4
Minnesota Urology
Bloomington, Minnesota, United States, 55420
Actively Recruiting
5
Mayo Clinic
Rochester, Minnesota, United States, 55950
Actively Recruiting
6
Wake Forest University of Health Sciences
Charlotte, North Carolina, United States, 28204
Actively Recruiting
7
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
8
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44106
Actively Recruiting
9
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
10
Urology Clinics of North Texas
Dallas, Texas, United States, 75231
Actively Recruiting
11
University of Texas, Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
12
University of Texas, MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
13
Urology of Virginia
Virginia Beach, Virginia, United States, 23462
Actively Recruiting
14
Centre Hospitalier Universitaire de Lille
Lille, France
Actively Recruiting
15
Hospitals Academics De Marseille Conception
Marseille, France
Actively Recruiting
16
Centre Hospitalier Universitaire de Nantes
Nantes, France
Actively Recruiting
17
Groupe Hospitalier Pitié-Salpêtrière
Paris, France
Actively Recruiting
18
Centre Hospitalier Univeritaire de Lyon - Hôpital Lyon Sud
Pierre-Bénite, France
Actively Recruiting
19
Centre Hospitalier Universitaire de Rennes
Rennes, France
Actively Recruiting
20
Centre Hospitalier Universitaire de Rouen
Rouen, France
Actively Recruiting
21
Hopital Foch
Suresnes, France
Actively Recruiting
Research Team
R
Roshini Jain
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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