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

NCT06968741 | Recruiting FDA Device

• 1 other identifier: CIP CSO2307120900
• Study Type: interventional
• Target: 140
• Locations: 2 countries
• Sites: 21

Brief Summary

Prospective, multicenter, single-arm study

Conditions

Stress Urinary Incontinence (SUI)

Keywords

Stress urinary incontinence; Artificial urinary sphincters

Outcome Measures

Primary Outcomes (1)

• Responder rate at 26 weeks post-activation

  Proportion of subjects who report greater than or equal to 50% reduction in the 24 hour Pad Weight Test (PWT) at 26 weeks compared with Baseline

  26 weeks

Other Outcomes (1)

• Proportion of subjects reporting change in overall impression of improvement (PGI-I)

  26 weeks

Study Arms (1)

UroActive AUS Implant

EXPERIMENTAL

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

Device: Artificial Urinary Sphincter (AUS)

Interventions

Artificial Urinary Sphincter (AUS) DEVICE

AUS implant

UroActive AUS Implant

Eligibility Criteria

• Age: 22 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UroMems SAS: lead

Study Sites (21)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94153, United States

RECRUITING

Stanford University

Stanford, California, 94305, United States

RECRUITING

Minnesota Urology

Bloomington, Minnesota, 55420, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55950, United States

RECRUITING

Wake Forest University of Health Sciences

Charlotte, North Carolina, 28204, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44106, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Urology Clinics of North Texas

Dallas, Texas, 75231, United States

RECRUITING

University of Texas, Southwestern

Dallas, Texas, 75390, United States

RECRUITING

University of Texas, MD Anderson

Houston, Texas, 77030, United States

RECRUITING

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

RECRUITING

Centre Hospitalier Universitaire de Lille

Lille, France

RECRUITING

Hospitals Academics De Marseille Conception

Marseille, France

RECRUITING

Centre Hospitalier Universitaire de Nantes

Nantes, France

RECRUITING

Groupe Hospitalier Pitié-Salpêtrière

Paris, France

RECRUITING

Centre Hospitalier Univeritaire de Lyon - Hôpital Lyon Sud

Pierre-Bénite, France

RECRUITING

Centre Hospitalier Universitaire de Rennes

Rennes, France

RECRUITING

Centre Hospitalier Universitaire de Rouen

Rouen, France

RECRUITING

Hopital Foch

Suresnes, France

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Urinary Sphincter, Artificial

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Artificial Organs; Surgical Equipment

Study Officials

• Roshini Jain

  UroMems SAS

  STUDY DIRECTOR

Central Study Contacts

Roshini Jain

CONTACT

14697669888; roshini.jain@uromems.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2031
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (13); FR (8)