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

NCT05828979 | Active Not Recruiting DMC

• 1 other identifier: CIP CCH2211240956
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Urinary Incontinence,Stress

Outcome Measures

Primary Outcomes (2)

• Rate of explants and revisions at 6 months after device activation

  Rate of explants and revisions

  6 months after device activation

• Rate of device activation successes

  Rate of device activation successes

  5 weeks after device implantation

Secondary Outcomes (13)

• Number of subjects with 50% reduction or greater in 24-hour pad weight test

  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

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

• 3-day bladder diary

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

• General quality of life questionnaire

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

• Disease specific questionnaire (level of incontinence)

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

Study Arms (1)

UroMems artificial urinary sphincter

EXPERIMENTAL

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

Device: UroMems artificial urinary sphincter

Interventions

UroMems artificial urinary sphincter DEVICE

Implantation of the device

UroMems artificial urinary sphincter

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UroMems SAS: lead

Study Sites (2)

CHU Nantes

Nantes, France

Location

Groupe Hospitalier Pitié-Salpêtrière

Paris, France

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emmanuel Chartier-Kastler

  Groupe Hospitalier Pitié-Salpêtrière

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 25, 2023
• Study Start: May 2, 2023
• Primary Completion: January 23, 2025
• Study Completion (Estimated): September 1, 2029
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)