Actively Recruiting

Phase Not Applicable
Age: 22Years +
MALE
NCT06968741

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

Age: 22Years +
MALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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