New implant aims to stop urine leakage in men

NCT ID NCT06968741

Recruiting now Disease control Sponsor: UroMems SAS Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new device called UrOActive®, an artificial urinary sphincter, in 140 men with stress urinary incontinence (leakage when coughing, sneezing, or moving). The device is implanted to help control urine flow. The main goal is to see if it reduces leakage by at least half after 26 weeks. The trial is currently recruiting participants.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: UrOActive® artificial urinary sphincter (implantable device)
What this could lead to: If successful, this device could offer men with stress urinary incontinence a new, effective option to control leakage and improve quality of life.
What could go wrong: This is an early-stage, single-arm study with no comparison group. The device may not work for everyone, and risks include infection, device malfunction, or need for removal.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

female stress incontinence Urinary Incontinence, Stress

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

STRESS URINARY INCONTINENCE (SUI)

Contacts and locations

Locations

Centre Hospitalier Univeritaire de Lyon - Hôpital Lyon Sud
RECRUITING

Pierre-Bénite, France
Centre Hospitalier Universitaire de Lille
RECRUITING

Lille, France
Centre Hospitalier Universitaire de Nantes
RECRUITING

Nantes, France
Centre Hospitalier Universitaire de Rennes
RECRUITING

Rennes, France
Centre Hospitalier Universitaire de Rouen
RECRUITING

Rouen, France
Cleveland Clinic Foundation
RECRUITING

Cleveland, Ohio, 44106, United States
Duke University
RECRUITING

Durham, North Carolina, 27710, United States
Groupe Hospitalier Pitié-Salpêtrière
RECRUITING

Paris, France
Hopital Foch
RECRUITING

Suresnes, France
Hospitals Academics De Marseille Conception
RECRUITING

Marseille, France
Mayo Clinic
RECRUITING

Rochester, Minnesota, 55950, United States
Minnesota Urology
RECRUITING

Bloomington, Minnesota, 55420, United States
Stanford University
RECRUITING

Stanford, California, 94305, United States
University of California, Los Angeles
RECRUITING

Los Angeles, California, 90095, United States
University of California, San Francisco
RECRUITING

San Francisco, California, 94153, United States
University of Texas, MD Anderson
RECRUITING

Houston, Texas, 77030, United States
University of Texas, Southwestern
RECRUITING

Dallas, Texas, 75390, United States
Urology Clinics of North Texas
RECRUITING

Dallas, Texas, 75231, United States
Urology of Virginia
RECRUITING

Virginia Beach, Virginia, 23462, United States
Vanderbilt University Medical Center
RECRUITING

Nashville, Tennessee, 37232, United States
Wake Forest University of Health Sciences
RECRUITING

Charlotte, North Carolina, 28204, United States

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