Stress Urinary Incontinence (SUI)SOPHIA2NCT06968741
A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)
A study testing Artificial Urinary Sphincter (AUS) in people with Stress Urinary Incontinence (SUI), run by UroMems SAS at 21 sites in 2 countries.
Trial summary
Prospective, multicenter, single-arm study Read more about this study
- Who is it for?
- Ages 22 years and older, men only
- Conditions the study is for
- Stress Urinary Incontinence (SUI)
- What is being tested?
- Artificial Urinary Sphincter (AUS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 19 May 2025to Dec 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States13 sites
Minnesota Urology
Bloomington, Minnesota, 55420
Wake Forest University of Health Sciences
Charlotte, North Carolina, 28204
Cleveland Clinic Foundation
Cleveland, Ohio, 44106
Urology Clinics of North Texas
Dallas, Texas, 75231
University of Texas, Southwestern
Dallas, Texas, 75390
Duke University
Durham, North Carolina, 27710
University of Texas, MD Anderson
Houston, Texas, 77030
University of California, Los Angeles
Los Angeles, California, 90095
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Mayo Clinic
Rochester, Minnesota, 55950
University of California, San Francisco
San Francisco, California, 94153
Stanford University
Stanford, California, 94305
Urology of Virginia
Virginia Beach, Virginia, 23462
France8 sites
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
About this study
Official title: Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter In the treAtment of Stress Urinary Incontinence in Men
Prospective, multicenter, single-arm study
- Conditions
- Stress Urinary Incontinence (SUI)
- Being tested
- Artificial Urinary Sphincter (AUS)
- Keywords
- Stress urinary incontinence, Artificial urinary sphincters
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Urinary Sphincter (AUS)Device
AUS implant
| Study group | Role | What they receive |
|---|---|---|
| UroActive AUS Implant | Experimental | Enrolled subjects who meet study eligibility criteria will proceed to receive the UroActive Artificial Urinary Sphincter (AUS) device Receives: Device: Artificial Urinary Sphincter (AUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start19 May 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary Incontinence (SUI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UroMems SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roshini Jain, Study director, UroMems SAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968741
- Sponsor's protocol ID
- CIP CSO2307120900
- Acronym
- SOPHIA2
- Status last verified
- Oct 2026
- First submitted
- 5 May 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No