Assessing the UrOActive® Artificial Urinary Sphincter for treating stress urinary incontinence
Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter In the treAtment of Stress Urinary Incontinence in Men
This study is testing the UrOActive® Artificial Urinary Sphincter to see if it can safely help men with stress urinary incontinence.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 22 Years and up |
| Sex | Male |
| Sponsor | UroMems SAS Industry-sponsored |
| Locations | 21 sites (Los Angeles, California and 20 other locations) |
| Trial ID | NCT06968741 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of the UrOActive® Artificial Urinary Sphincter (AUS) in male patients suffering from stress urinary incontinence (SUI). It is a prospective, multicenter, single-arm study that aims to gather data on the device's performance and patient outcomes. Participants will undergo the AUS implantation and will be monitored for safety and efficacy over a specified period. The study seeks to provide insights into the long-term benefits and potential risks associated with this intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are male subjects aged 22 years and older with a primary diagnosis of stress urinary incontinence for at least six months.
Not a fit: Patients with urge incontinence or mixed incontinence with a predominant urgency component may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for patients suffering from stress urinary incontinence.
How similar studies have performed: Other studies on artificial urinary sphincters have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California and 20 other locations
- University of California, Los Angeles — Los Angeles, California, United States (Recruiting)
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- Stanford University — Stanford, California, United States (Recruiting)
- Minnesota Urology — Bloomington, Minnesota, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Wake Forest University of Health Sciences — Charlotte, North Carolina, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- Urology Clinics of North Texas — Dallas, Texas, United States (Recruiting)
- University of Texas, Southwestern — Dallas, Texas, United States (Recruiting)
- University of Texas, MD Anderson — Houston, Texas, United States (Recruiting)
- Urology of Virginia — Virginia Beach, Virginia, 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)
Study contacts
- Study coordinator: Roshini Jain
- Email: roshini.jain@uromems.com
- Phone: 14697669888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.