Recruiting NCT06968741
A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Artificial Urinary Sphincter (AUS).
- Who it may be relevant to
- Registry conditions: Stress Urinary Incontinence (SUI). Basic parameters: from 22 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter In the treAtment of Stress Urinary Incontinence in Men
Overview
Prospective, multicenter, single-arm study
Interventions
- Device Artificial Urinary Sphincter (AUS)
AUS implant
Primary outcome measures
- Responder rate at 26 weeks post-activation [Time frame: 26 weeks]
Eligibility criteria
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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 13 centers
- University of California, Los Angeles — Los Angeles
- University of California, San Francisco — San Francisco
- Stanford University — Stanford
- Minnesota Urology — Bloomington
- Mayo Clinic — Rochester
- Wake Forest University of Health Sciences — Charlotte
- Duke University — Durham
- Cleveland Clinic Foundation — Cleveland
- … and 5 more centers
France · 8 centers
- Centre Hospitalier Universitaire de Lille — Lille
- Hospitals Academics De Marseille Conception — Marseille
- Centre Hospitalier Universitaire de Nantes — Nantes
- Groupe Hospitalier Pitié-Salpêtrière — Paris
- Centre Hospitalier Univeritaire de Lyon - Hôpital Lyon Sud — Pierre-Bénite
- Centre Hospitalier Universitaire de Rennes — Rennes
- Centre Hospitalier Universitaire de Rouen — Rouen
- Hopital Foch — Suresnes
Identifiers
NCT: NCT06968741 · CIP CSO2307120900