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

Urinary Incontinence,Stress Clinical Trial

— SOPHIA  

Official title:

First-in-human Study to Assess the UrOMems Artificial Urinary sPHincter In the treAtment of Stress Incontinence

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05547672
• Other study ID #: CIP CSO2012031234
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 31, 2022
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: UroMems SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: June 2025
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged >18 years old

• Male 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

• 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, Pro-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 him from giving his consent, patients hospitalized for reason other than the current clinical investigation, patient under 18 years of age, patient under tutelage, patient having withdrawn his consent)

• Patients whom the investigator determines to be poor candidate for surgical procedures and/or anesthesia due to physical or mental conditions

• 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

• Known allergy to intravenous iodine

• Abnormal Prostate Screening Antigen (PSA), according to site's laboratory standards, unless further investigation confirms the absence of primary prostate cancer or local recurrence assessed by investigator.

• 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, except prostate cancer

• 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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence,Stress

Intervention

Device:
• UroMems artificial urinary sphincter
Implantation of the device

Locations

Country	Name	City	State
France	CHU Nantes	Nantes
France	Groupe Hospitalier Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
UroMems SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of explants and revisions at 6 months after device activation	Rate of explants and revisions	6 months after device activation
Primary	Rate of device activation successes	Rate of device activation successes	5 weeks after device implantation
Secondary	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	90, 185 and 365 days after activation
Secondary	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	90, 185 and 365 days after activation
Secondary	3-day bladder diary	Bladder diary will be filled in during 3 consecutive days	90, 185 and 365 days after activation
Secondary	General quality of life questionnaire	General quality of life questionnaire	90, 185 and 365 days after activation
Secondary	Disease specific questionnaire (level of incontinence)	Disease specific questionnaire (level of incontinence)	90, 185 and 365 days after activation
Secondary	Disease specific questionnaire (symptoms and quality of life)	Disease specific questionnaire (symptoms and quality of life)	90, 185 and 365 days after activation
Secondary	Disease specific questionnaire (sexual activity)	Disease specific questionnaire (sexual activity)	90, 185 and 365 days after activation
Secondary	Disease specific questionnaire (quality of life)	Disease specific questionnaire (quality of life)	90, 185 and 365 days after activation
Secondary	Disease specific questionnaire (type of incontinence)	Disease specific questionnaire (type of incontinence)	90, 185 and 365 days after activation
Secondary	Post void residuals	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, 365 and 730 days after activation
Secondary	Patient satisfaction	Patient satisfaction questionnaire	5 weeks after device implantation (device activation), and 14, 30, 90, 185, 365 and 730 days after activation
Secondary	Physician satisfaction questionnaire	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, 365 and 730 days after activation
Secondary	Rate of adverse events	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, 365 and 730 days after activation