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New implant aims to stop urine leakage in men

NCT ID NCT06968741

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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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)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.