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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Urinary Incontinence,Stress
• Intervention / Treatment: Device: UroMems artificial urinary sphincter

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).

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UroMems artificial urinary sphincter; Male adults (18+) with urinary incontinence with reduced outlet resistance due to intrinsic sphincter deficiency. Intervention: device (UroMems artificial urinary sphincter)	Device: UroMems artificial urinary sphincter; Implantation of the device

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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 days and annually up to 5-years after activation
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 days and annually up to 5-years after activation
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 days and annually up to 5-years after activation
Patient satisfaction	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	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	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
3-day bladder diary	Bladder diary will be filled in during 3 consecutive days	90, 185 days and annually up to 5-years after activation
General quality of life questionnaire	General quality of life questionnaire	90, 185 days and annually up to 5-years after activation
Disease specific questionnaire (level of incontinence)	Disease specific questionnaire (level of incontinence)	90, 185 days and annually up to 5-years after activation
Disease specific questionnaire (symptoms and quality of life)	Disease specific questionnaire (symptoms and quality of life)	90, 185 days and annually up to 5-years after activation
Disease specific questionnaire (sexual activity)	Disease specific questionnaire (sexual activity)	90, 185 days and annually up to 5-years after activation
Disease specific questionnaire (quality of life)	Disease specific questionnaire (quality of life)	90, 185 days and annually up to 5-years after activation
Disease specific questionnaire (type of incontinence)	Disease specific questionnaire (type of incontinence)	90, 185 days and annually up to 5-years after activation

Collaborators and Investigators

• Sponsor: UroMems SAS
• Investigators: Principal Investigator: Emmanuel Chartier-Kastler, Groupe Hospitalier Pitie-Salpetriere

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2022
• Primary Completion (Actual): November 30, 2023
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence, Stress
• Other Study ID Numbers: CIP CSO2012031234

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