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

Primary Purpose

Urinary Incontinence,Stress

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
UroMems artificial urinary sphincter
Sponsored by
UroMems SAS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence,Stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Nantes
  • Groupe Hospitalier Pitié-SalpêtrièreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UroMems artificial urinary sphincter

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
3-day bladder diary
Bladder diary will be filled in during 3 consecutive days
General quality of life questionnaire
General quality of life questionnaire
Disease specific questionnaire (level of incontinence)
Disease specific questionnaire (level of incontinence)
Disease specific questionnaire (symptoms and quality of life)
Disease specific questionnaire (symptoms and quality of life)
Disease specific questionnaire (sexual activity)
Disease specific questionnaire (sexual activity)
Disease specific questionnaire (quality of life)
Disease specific questionnaire (quality of life)
Disease specific questionnaire (type of incontinence)
Disease specific questionnaire (type of incontinence)
Post void residuals
Post void residuals will be measured to assess the bladder function
Patient satisfaction
Patient satisfaction questionnaire
Physician satisfaction questionnaire
Questionnaire to assess the physician satisfaction regarding the procedure and the device
Rate of adverse events
All categories: serious/not serious events and device- and procedure-related effects

Full Information

First Posted
April 12, 2023
Last Updated
September 13, 2023
Sponsor
UroMems SAS
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1. Study Identification

Unique Protocol Identification Number
NCT05828979
Brief Title
Clinical Investigation to Assess a New Artificial Urinary Sphincter to Treat Urinary Incontinence in Women
Official Title
Feasibility sTudy to Assess the URoMems Artificial uriNary Sphincter In the Treatment of Stress Incontinence in wOmeN
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UroMems SAS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence,Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UroMems artificial urinary sphincter
Arm Type
Experimental
Arm Description
Female adults (18+) with urinary incontinence with reduced outlet resistance due to intrinsic sphincter deficiency.
Intervention Type
Device
Intervention Name(s)
UroMems artificial urinary sphincter
Intervention Description
Implantation of the device
Primary Outcome Measure Information:
Title
Rate of explants and revisions at 6 months after device activation
Description
Rate of explants and revisions
Time Frame
6 months after device activation
Title
Rate of device activation successes
Description
Rate of device activation successes
Time Frame
5 weeks after device implantation
Secondary Outcome Measure Information:
Title
Number of subjects with 50% reduction or greater in 24-hour pad weight test
Description
Number of subjects with 50% reduction or greater in 24-hour pad weight test
Time Frame
90, 185 and 365 days after activation
Title
Number of subjects with 75% reduction or greater in 24-hour pad weight test
Description
Number of subjects with 75% reduction or greater in 24-hour pad weight test
Time Frame
90, 185 and 365 days after activation
Title
3-day bladder diary
Description
Bladder diary will be filled in during 3 consecutive days
Time Frame
90, 185 and 365 days after activation
Title
General quality of life questionnaire
Description
General quality of life questionnaire
Time Frame
90, 185 and 365 days after activation
Title
Disease specific questionnaire (level of incontinence)
Description
Disease specific questionnaire (level of incontinence)
Time Frame
90, 185 and 365 days after activation
Title
Disease specific questionnaire (symptoms and quality of life)
Description
Disease specific questionnaire (symptoms and quality of life)
Time Frame
90, 185 and 365 days after activation
Title
Disease specific questionnaire (sexual activity)
Description
Disease specific questionnaire (sexual activity)
Time Frame
90, 185 and 365 days after activation
Title
Disease specific questionnaire (quality of life)
Description
Disease specific questionnaire (quality of life)
Time Frame
90, 185 and 365 days after activation
Title
Disease specific questionnaire (type of incontinence)
Description
Disease specific questionnaire (type of incontinence)
Time Frame
90, 185 and 365 days after activation
Title
Post void residuals
Description
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, 365 and 730 days after activation
Title
Patient satisfaction
Description
Patient satisfaction questionnaire
Time Frame
5 weeks after device implantation (device activation), and 14, 30, 90, 185, 365 and 730 days after activation
Title
Physician satisfaction questionnaire
Description
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, 365 and 730 days after activation
Title
Rate of adverse events
Description
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, 365 and 730 days after activation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Soufflet
Phone
+33480420240
Email
caroline.soufflet@uromems.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel Chartier-Kastler
Organizational Affiliation
Groupe Hospitalier Pitié-Salpêtrière
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Nantes
City
Nantes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Aimée Perrouin-Verbe
First Name & Middle Initial & Last Name & Degree
Marie-Aimée Perrouin-Verbe
Facility Name
Groupe Hospitalier Pitié-Salpêtrière
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel Chartier-Kastler
First Name & Middle Initial & Last Name & Degree
Emmanuel Chartier-Kastler

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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