Actively Recruiting
A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)
Led by UroMems SAS · Updated on 2026-03-27
140
Participants Needed
21
Research Sites
341 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective, multicenter, single-arm study
CONDITIONS
Official 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 63 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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