- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05828979
Clinical Investigation to Assess a New Artificial Urinary Sphincter to Treat Urinary Incontinence in Women (TRANSITION)
September 13, 2023 updated by: UroMems SAS
Feasibility sTudy to Assess the URoMems Artificial uriNary Sphincter In the Treatment of Stress Incontinence in wOmeN
Prospective multicenter study designed to test the feasibility of the UroMems Artificial Urinary Sphincter in women
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Caroline Soufflet
- Phone Number: +33480420240
- Email: caroline.soufflet@uromems.com
Study Locations
-
-
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Nantes, France
- Not yet recruiting
- CHU Nantes
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Contact:
- Marie-Aimée Perrouin-Verbe
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Principal Investigator:
- Marie-Aimée Perrouin-Verbe
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Paris, France
- Recruiting
- Groupe Hospitalier Pitie-Salpetriere
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Principal Investigator:
- Emmanuel Chartier-Kastler
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Contact:
- Emmanuel Chartier-Kastler
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: UroMems artificial urinary sphincter
Female adults (18+) with urinary incontinence with reduced outlet resistance due to intrinsic sphincter deficiency.
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Implantation of the device
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of explants and revisions at 6 months after device activation
Time Frame: 6 months after device activation
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Rate of explants and revisions
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6 months after device activation
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Rate of device activation successes
Time Frame: 5 weeks after device implantation
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Rate of device activation successes
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5 weeks after device implantation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects with 50% reduction or greater in 24-hour pad weight test
Time Frame: 90, 185 and 365 days after activation
|
Number of subjects with 50% reduction or greater in 24-hour pad weight test
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90, 185 and 365 days after activation
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Number of subjects with 75% reduction or greater in 24-hour pad weight test
Time Frame: 90, 185 and 365 days after activation
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Number of subjects with 75% reduction or greater in 24-hour pad weight test
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90, 185 and 365 days after activation
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3-day bladder diary
Time Frame: 90, 185 and 365 days after activation
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Bladder diary will be filled in during 3 consecutive days
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90, 185 and 365 days after activation
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General quality of life questionnaire
Time Frame: 90, 185 and 365 days after activation
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General quality of life questionnaire
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90, 185 and 365 days after activation
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Disease specific questionnaire (level of incontinence)
Time Frame: 90, 185 and 365 days after activation
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Disease specific questionnaire (level of incontinence)
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90, 185 and 365 days after activation
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Disease specific questionnaire (symptoms and quality of life)
Time Frame: 90, 185 and 365 days after activation
|
Disease specific questionnaire (symptoms and quality of life)
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90, 185 and 365 days after activation
|
Disease specific questionnaire (sexual activity)
Time Frame: 90, 185 and 365 days after activation
|
Disease specific questionnaire (sexual activity)
|
90, 185 and 365 days after activation
|
Disease specific questionnaire (quality of life)
Time Frame: 90, 185 and 365 days after activation
|
Disease specific questionnaire (quality of life)
|
90, 185 and 365 days after activation
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Disease specific questionnaire (type of incontinence)
Time Frame: 90, 185 and 365 days after activation
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Disease specific questionnaire (type of incontinence)
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90, 185 and 365 days after activation
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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, 365 and 730 days after activation
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Post void residuals will be measured to assess the bladder function
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Baseline, within 45 days after baseline (device implantation), 14 days after implantation, 5 weeks after implantation (device activation), and 14, 30, 90, 185, 365 and 730 days after activation
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Patient satisfaction
Time Frame: 5 weeks after device implantation (device activation), and 14, 30, 90, 185, 365 and 730 days after activation
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Patient satisfaction questionnaire
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5 weeks after device implantation (device activation), and 14, 30, 90, 185, 365 and 730 days after activation
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Physician satisfaction questionnaire
Time Frame: Within 45 days after baseline (device implantation), 5 weeks after implantation (device activation), and 14, 30, 90, 185, 365 and 730 days after activation
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Questionnaire to assess the physician satisfaction regarding the procedure and the device
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Within 45 days after baseline (device implantation), 5 weeks after implantation (device activation), and 14, 30, 90, 185, 365 and 730 days after activation
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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, 365 and 730 days after activation
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All categories: serious/not serious events and device- and procedure-related effects
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Baseline, within 45 days after baseline (device implantation), 14 days after implantation, 5 weeks after implantation (device activation), and 14, 30, 90, 185, 365 and 730 days after activation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Emmanuel Chartier-Kastler, Groupe Hospitalier Pitie-Salpetriere
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 2, 2023
Primary Completion (Estimated)
July 1, 2024
Study Completion (Estimated)
November 1, 2025
Study Registration Dates
First Submitted
April 12, 2023
First Submitted That Met QC Criteria
April 12, 2023
First Posted (Actual)
April 25, 2023
Study Record Updates
Last Update Posted (Actual)
September 15, 2023
Last Update Submitted That Met QC Criteria
September 13, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urination Disorders
- Elimination Disorders
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Urinary Incontinence
- Enuresis
- Urinary Incontinence, Stress
Other Study ID Numbers
- CIP CCH2211240956
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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