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Active, not recruitingNCT05828979Updated Apr 1, 2026

Clinical Investigation to Assess a New Artificial Urinary Sphincter to Treat Urinary Incontinence in Women

An interventional study of UroMems artificial urinary sphincter in Urinary Incontinence,Stress, sponsored by UroMems SAS. Active, not recruiting at 2 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.

Sponsored by UroMems SAS · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

Prospective multicenter study designed to test the feasibility of the UroMems Artificial Urinary Sphincter in women

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) in women.

02

Conditions studied

  • Urinary Incontinence,Stress
03

In context

Urinary Incontinence, Stress

658 studies on the registry are indexed under Urinary Incontinence, Stress; 123 are open to participants now.

This study's planned enrollment of 6 is below the median of 70 across 509 interventional studies indexed under Urinary Incontinence, Stress.

Browse Urinary Incontinence, Stress studies →

Lead sponsor

UroMems SAS is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Aged >18 years old
  • Female 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
  • Use of medically acceptable contraception, if of childbearing potential
  • 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
  • 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, 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

Exclusion criteria

Exclusion Criteria:

  • 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 her from giving her consent, patients hospitalized for reason other than the current clinical investigation, patient under 18 years of age, patient under tutelage, patient having withdrawn her consent)
  • Patients whom the investigator determines to be poor candidate for surgical procedures and/or anesthesia due to physical or mental conditions
  • Pregnant patient, or patient planning pregnancy during the study duration
  • 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
  • History of pelvic irradiation (external beam therapy or brachytherapy)
  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (estimated)

Study arms

  • Experimental
    UroMems artificial urinary sphincter

    Female adults (18+) with urinary incontinence with reduced outlet resistance due to intrinsic sphincter deficiency.

    Device: UroMems artificial urinary sphincter

Interventions

  • DeviceUroMems artificial urinary sphincter

    Implantation of the device

06

What researchers measure

Primary outcomes

  1. Rate of explants and revisions at 6 months after device activation

    Rate of explants and revisions

    Time frame: 6 months after device activation

  2. Rate of device activation successes

    Rate of device activation successes

    Time frame: 5 weeks after device implantation

Secondary outcomes

  1. 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

    Time frame: 90, 185 days and annually up to 5-years after activation

  2. 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

    Time frame: 90, 185 days and annually up to 5-years after activation

  3. 3-day bladder diary

    Bladder diary will be filled in during 3 consecutive days

    Time frame: at baseline, at device activation, and 90-days, 185-days and annually up to 5-years after activation

  4. General quality of life questionnaire

    General quality of life questionnaire

    Time frame: at baseline, at device activation and 90-days, 185-days and annually up to 5-years after activation

  5. Disease specific questionnaire (level of incontinence)

    Disease specific questionnaire (level of incontinence)

    Time frame: at baseline, at device activation and 90-days, 185-days and annually up to 5-years after activation

  6. Disease specific questionnaire (symptoms and quality of life)

    Disease specific questionnaire (symptoms and quality of life)

    Time frame: at baseline, at device activation and 90-days, 185-days and annually up to 5-years after activation

  7. Disease specific questionnaire (sexual activity)

    Disease specific questionnaire (sexual activity)

    Time frame: at baseline, at device activation and 90-days, 185-days and annually up to 5-years after activation

  8. Disease specific questionnaire (quality of life)

    Disease specific questionnaire (quality of life)

    Time frame: at baseline, at device activation and 90-days, 185-days and annually up to 5-years after activation

  9. Disease specific questionnaire (type of incontinence)

    Disease specific questionnaire (type of incontinence)

    Time frame: at baseline, at device activation and 90-days, 185-days and annually up to 5-years after activation

  10. Post void residuals

    Post void residuals will be measured to assess the bladder function

    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

  11. Patient satisfaction

    Patient satisfaction questionnaire

    Time frame: 5 weeks after device implantation (device activation), and 14, 30, 90, 185 days and annually up to 5-years after activation

  12. Physician satisfaction questionnaire

    Questionnaire to assess the physician satisfaction regarding the procedure and the device

    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

  13. Rate of adverse events

    All categories: serious/not serious events and device- and procedure-related effects

    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

07

Study locations

2 sites
  • CHU Nantes
    Nantes, France
  • Groupe Hospitalier Pitié-Salpêtrière
    Paris, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05828979
Lead sponsor
UroMems SAS
Responsible party
Sponsor
First posted
Apr 25, 2023
Start date
May 2, 2023
Primary completion
Jan 23, 2025
Completion
Sep 2029 (estimated)
Last update
Apr 1, 2026

Study contacts

Emmanuel Chartier-Kastler
principal investigator · Groupe Hospitalier Pitie-Salpetriere

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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