Urinary Incontinence,StressSOPHIANCT05547672
Clinical Investigation to Assess a New Artificial Urinary Sphincter to Treat Urinary Incontinence in Men
A study testing UroMems artificial urinary sphincter in people with Urinary Incontinence,Stress, run by UroMems SAS at 2 sites in France.
Trial summary
Prospective multicenter study designed to test the feasibility of the UroMems Artificial Urinary Sphincter. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Incontinence,Stress
- What is being tested?
- UroMems artificial urinary sphincter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesFrance
- Study dates
- 31 Aug 2022to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged >18 years old
- Male patient
- Cognitively able and willing to sign an informed consent
- Stable medication regimen (including prescription, over the counter, and supplements) for the past 3 months
- Able and willing to comply with follow-up investigations, including maintaining consistent medication use and fluid intake through the primary endpoints
- Has adequate cognitive and manual capabilities to operate the UroMems eAUS System as assessed by the investigator
Show all 14Show fewer
- Is an appropriate surgical candidate and has no medical or mental condition that would interfere with study procedures or confound study outcomes as assessed by the investigator
- Life expectancy ≥ 5 years as assessed by the investigator
- Affiliated with an appropriate social security system
- Has failed or is not a candidate for other treatments for urinary incontinence, either surgical or conservative, including slings, Pro-ACT, etc. (excluding other AUS devices)
- Negative urine culture prior to the procedure
- Urinary incontinence assessed by investigator with at least ≥ 50 g in 24-hour pad-weight tests
- Clinically insignificant post-void residual (PVR) urine defined as < 50 ml and/or no greater than 10% of the voided volume
- Complains of urine leakage on coughing, laughing, and/or moving and/or presence of orthostatic urine leakage by self-report as recorded in baseline bladder diary
Who cannot join
- Currently enrolled or plans to enroll in another investigational device or clinical drug trial or has completed an investigational study within 3 months
- Vulnerable patient (patient deprived of their liberty due to a judicial or administrative decision, patient suffering from psychiatry troubles preventing him from giving his consent, patients hospitalized for reason other than the current clinical investigation, patient under 18 years of age, patient under tutelage, patient having withdrawn his consent)
- Patients whom the investigator determines to be poor candidate for surgical procedures and/or anesthesia due to physical or mental conditions
- Patient presenting one or several contraindications of the device
- Any planned procedure requiring urethral catheterization 12 months after implant procedure (include intermittent catheterization) except for diagnostic purposes
- Known allergy to UroMems eAUS implantable components
Show all 18Show fewer
- Known allergy to intravenous iodine
- Abnormal Prostate Screening Antigen (PSA), according to site's laboratory standards, unless further investigation confirms the absence of primary prostate cancer or local recurrence assessed by investigator.
- Uncontrolled diabetes mellitus defined as persistent blood sugar level recordings of >12 mmol/l (216 mg/dl) and a glycosylated hemoglobin (HbA1C) of >9% (75 mmol/mol) over the preceding 3 months
- History of bleeding diathesis or cannot stop usage of an anti-coagulant until the International Normalized Ratio (INR) is below 1.5 or quick value >70
- Any genito-urinary malignancies which are not in remission for at least 2 years or considered cured, except prostate cancer
- Previous AUS implant
- Currently has another Active Implantable Medical Device (AIMD) implanted
- Urge incontinence, mixed incontinence (MI) with a predominant urgency component
- Overflow urinary incontinence
- Neurogenic bladder dysfunction that is not treatable or controllable by pharmacological or any alternative methods
- Abnormal or poor bladder compliance defined as being <30 ml/ cm H2O
- Bladder neck or urethral stricture that may require any long-term instrumental treatment
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: First-in-human Study to Assess the UrOMems Artificial Urinary sPHincter In the treAtment of Stress Incontinence
Prospective multicenter study designed to test the feasibility of the UroMems Artificial Urinary Sphincter.
Read the detailed description
This study is a prospective, open-label, non-randomized, multi-center, single-arm, study with subjects acting as their own control designed to test the feasibility of a new artificial urinary sphincter the UroMems eAUS (investigational name of device called UroActive).
- Conditions
- Urinary Incontinence,Stress
- Being tested
- UroMems artificial urinary sphincter
- 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.
UroMems artificial urinary sphincterDevice
Implantation of the device
| Study group | Role | What they receive |
|---|---|---|
| UroMems artificial urinary sphincter | Experimental | Male adults (18+) with urinary incontinence with reduced outlet resistance due to intrinsic sphincter deficiency.
Intervention: device (UroMems artificial urinary sphincter) Receives: Device: UroMems artificial urinary sphincter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of explants and revisions at 6 months after device activation
Rate of explants and revisions
Measured: 6 months after device activation
Rate of device activation successes
Rate of device activation successes
Measured: 5 weeks after device implantation
Secondary outcomes (13)
Number of subjects with 50% reduction or greater in 24-hour pad weight test
Number of subjects with 50% reduction or greater in 24-hour pad weight test
Measured: 90, 185 days and annually up to 5-years after activation
Number of subjects with 75% reduction or greater in 24-hour pad weight test
Number of subjects with 75% reduction or greater in 24-hour pad weight test
Measured: 90, 185 days and annually up to 5-years after activation
3-day bladder diary
Bladder diary will be filled in during 3 consecutive days
Measured: 90, 185 days and annually up to 5-years after activation
General quality of life questionnaire
General quality of life questionnaire
Measured: 90, 185 days and annually up to 5-years after activation
Disease specific questionnaire (level of incontinence)
Disease specific questionnaire (level of incontinence)
Measured: 90, 185 days and annually up to 5-years after activation
Disease specific questionnaire (symptoms and quality of life)
Disease specific questionnaire (symptoms and quality of life)
Measured: 90, 185 days and annually up to 5-years after activation
Disease specific questionnaire (sexual activity)
Disease specific questionnaire (sexual activity)
Measured: 90, 185 days and annually up to 5-years after activation
Disease specific questionnaire (quality of life)
Disease specific questionnaire (quality of life)
Measured: 90, 185 days and annually up to 5-years after activation
Disease specific questionnaire (type of incontinence)
Disease specific questionnaire (type of incontinence)
Measured: 90, 185 days and annually up to 5-years after activation
Post void residuals
Post void residuals will be measured to assess the bladder function
Measured: Baseline, within 45 days after baseline (device implantation), 14 days after implantation, 5 weeks after implantation (device activation), and 14, 30, 90, 185 days and annually up to 5-years after activation
Patient satisfaction
Patient satisfaction questionnaire
Measured: 5 weeks after device implantation (device activation), and 14, 30, 90, 185 days and annually up to 5-years after activation
Physician satisfaction questionnaire
Questionnaire to assess the physician satisfaction regarding the procedure and the device
Measured: Within 45 days after baseline (device implantation), 5 weeks after implantation (device activation), and 14, 30, 90, 185 days and annually up to 5-years after activation
Rate of adverse events
All categories: serious/not serious events and device- and procedure-related effects
Measured: Baseline, within 45 days after baseline (device implantation), 14 days after implantation, 5 weeks after implantation (device activation), and 14, 30, 90, 185 days and annually up to 5-years after activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start31 Aug 2022
- Primary completion30 Nov 2023
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence,StressStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- UroMems SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emmanuel Chartier-Kastler, Principal investigator, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547672
- Sponsor's protocol ID
- CIP CSO2012031234
- Acronym
- SOPHIA
- Status last verified
- Mar 2026
- First submitted
- 12 Sep 2022
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-human Study to Assess the UrOMems Artificial Urinary sPHincter In the treAtment of Stress Incontinence
- ClinicalTrials.gov ID
- NCT05547672
- Acronym / sponsor ID
- SOPHIA / CIP CSO2012031234
- Conditions
- Urinary Incontinence,Stress
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- UroMems SASIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- Jul 2028 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective multicenter study designed to test the feasibility of the UroMems Artificial Urinary Sphincter.
Detailed description
This study is a prospective, open-label, non-randomized, multi-center, single-arm, study with subjects acting as their own control designed to test the feasibility of a new artificial urinary sphincter the UroMems eAUS (investigational name of device called UroActive).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UroMems artificial urinary sphincter | Experimental | Device: UroMems artificial urinary sphincterMale adults (18+) with urinary incontinence with reduced outlet resistance due to intrinsic sphincter deficiency. Intervention: device (UroMems artificial urinary sphincter) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Aged >18 years old
- Male patient
- Cognitively able and willing to sign an informed consent
- Stable medication regimen (including prescription, over the counter, and supplements) for the past 3 months
- Able and willing to comply with follow-up investigations, including maintaining consistent medication use and fluid intake through the primary endpoints
Key exclusion criteria (18 listed)
- Currently enrolled or plans to enroll in another investigational device or clinical drug trial or has completed an investigational study within 3 months
- Vulnerable patient (patient deprived of their liberty due to a judicial or administrative decision, patient suffering from psychiatry troubles preventing him from giving his consent, patients hospitalized for reason other than the current clinical investigation, patient under 18 years of age, patient under tutelage, patient having withdrawn his consent)
- Patients whom the investigator determines to be poor candidate for surgical procedures and/or anesthesia due to physical or mental conditions
- Patient presenting one or several contraindications of the device
- Any planned procedure requiring urethral catheterization 12 months after implant procedure (include intermittent catheterization) except for diagnostic purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UroMems artificial urinary sphincterImplantation of the device | Device | UroMems artificial urinary sphincter |
Primary outcome
Rate of explants and revisions at 6 months after device activation
Time frame: 6 months after device activation
Rate of explants and revisions
Rate of device activation successes
Time frame: 5 weeks after device implantation
Rate of device activation successes
13 secondary outcomes
Number of subjects with 50% reduction or greater in 24-hour pad weight test
Time frame: 90, 185 days and annually up to 5-years after activation
Number of subjects with 75% reduction or greater in 24-hour pad weight test
Time frame: 90, 185 days and annually up to 5-years after activation
3-day bladder diary
Time frame: 90, 185 days and annually up to 5-years after activation
General quality of life questionnaire
Time frame: 90, 185 days and annually up to 5-years after activation
Disease specific questionnaire (level of incontinence)
Time frame: 90, 185 days and annually up to 5-years after activation
Disease specific questionnaire (symptoms and quality of life)
Time frame: 90, 185 days and annually up to 5-years after activation
Disease specific questionnaire (sexual activity)
Time frame: 90, 185 days and annually up to 5-years after activation
Disease specific questionnaire (quality of life)
Time frame: 90, 185 days and annually up to 5-years after activation
Disease specific questionnaire (type of incontinence)
Time frame: 90, 185 days and annually up to 5-years after activation
Post void residuals
Time frame: Baseline, within 45 days after baseline (device implantation), 14 days after implantation, 5 weeks after implantation (device activation), and 14, 30, 90, 185 days and annually up to 5-years after activation
Patient satisfaction
Time frame: 5 weeks after device implantation (device activation), and 14, 30, 90, 185 days and annually up to 5-years after activation
Physician satisfaction questionnaire
Time frame: Within 45 days after baseline (device implantation), 5 weeks after implantation (device activation), and 14, 30, 90, 185 days and annually up to 5-years after activation
Rate of adverse events
Time frame: Baseline, within 45 days after baseline (device implantation), 14 days after implantation, 5 weeks after implantation (device activation), and 14, 30, 90, 185 days and annually up to 5-years after activation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Urinary Incontinence,Stress
RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Chartier-Kastler principal investigator
Groupe Hospitalier Pitie-Salpetriere
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UroMems artificial urinary sphincter in people with Urinary Incontinence,Stress, run by UroMems SAS at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of explants and revisions at 6 months after device activation (time frame: 6 months after device activation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.