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

March 26, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Nantes, France
        • CHU Nantes
      • Paris, France
        • Groupe Hospitalier Pitie-Salpetriere

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Implantation of the device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of explants and revisions at 6 months after device activation
Time Frame: 6 months after device activation
Rate of explants and revisions
6 months after device activation
Rate of device activation successes
Time Frame: 5 weeks after device implantation
Rate of device activation successes
5 weeks after device implantation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 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
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
90, 185 days and annually up to 5-years after activation
3-day bladder diary
Time Frame: at baseline, at device activation, and 90-days, 185-days and annually up to 5-years after activation
Bladder diary will be filled in during 3 consecutive days
at baseline, at device activation, and 90-days, 185-days and annually up to 5-years after activation
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
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)
Time Frame: 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
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
Disease specific questionnaire (symptoms and quality of life)
at baseline, at device activation and 90-days, 185-days and annually up to 5-years after activation
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
Disease specific questionnaire (sexual activity)
at baseline, at device activation and 90-days, 185-days and annually up to 5-years after activation
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
Disease specific questionnaire (quality of life)
at baseline, at device activation and 90-days, 185-days and annually up to 5-years after activation
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
Disease specific questionnaire (type of incontinence)
at baseline, at device activation and 90-days, 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
Post void residuals will be measured to assess the bladder function
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
Patient satisfaction questionnaire
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
Questionnaire to assess the physician satisfaction regarding the procedure and the device
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
All categories: serious/not serious events and device- and procedure-related effects
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UroMems SAS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 23, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

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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