Recruiting

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

Sponsor:

UroMems SAS

Code:

NCT06968741

Conditions

Stress Urinary Incontinence (SUI)

Eligibility Criteria

Sex: Male

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Artificial Urinary Sphincter (AUS)

Study Details

Brief summary:

Prospective, multicenter, single-arm study

Conditions

Stress Urinary Incontinence (SUI)

Study ID

NCT06968741

Start date

May 19, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: Male

Age: 22+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

Study Design

Enrollment

140 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: UroActive AUS Implant

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

Interventions

Artificial Urinary Sphincter (AUS)

AUS implant

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Roshini Jain

14697669888 roshini.jain@uromems.com

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Victor Nitti, MD

VNitti@mednet.ucla.edu

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94153

Contacts

Benjamin Breyer, MD

Benjamin.Breyer@ucsf.edu

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Craig Comiter, MD

ccomiter@stanford.edu

Minnesota Urology

Recruiting

Bloomington, Minnesota, United States, 55420

Contacts

Michael Ehlert, MD

MEhlert@mnurology.com

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55950

Contacts

Daniel Elliott, MD

elliott.daniel@mayo.edu

Wake Forest University of Health Sciences

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Michael Kennelly, MD

Michael.Kennelly@wfusm.edu

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Andrew Peterson, MD

drew.peterson@duke.edu

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Kenneth Angermeier, MD

angermk@ccf.org

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Melissa Kaufman, MD

melissa.kaufman@vumc.org

Urology Clinics of North Texas

Recruiting

Dallas, Texas, United States, 75231

Contacts

Allen Morey, MD

amorey@urologyclinics.com

University of Texas, Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Steven Hudak, MD

Steven.Hudak@UTSouthwestern.edu

University of Texas, MD Anderson

Recruiting

Houston, Texas, United States, 77030

Contacts

Lenaine Westney, MD

owestney@mdanderson.org

Urology of Virginia

Recruiting

Virginia Beach, Virginia, United States, 23462

Contacts

Kurt McCammon, MD

kurtmccammon@urologyofva.net

More Information

Sponsor

UroMems SAS

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

Stress urinary incontinence
Artificial urinary sphincters

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UroMems SAS on 2026-03-27.