Clinical trial NCT05547672: Clinical Investigation to Assess a New Artificial Urinary Sphincter to Treat Urinary Incontinence in Men
Official title: First-in-human Study to Assess the UrOMems Artificial Urinary sPHincter In the treAtment of Stress Incontinence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Urinary Incontinence,Stress
Lead sponsor: UroMems SAS
Sponsor class: INDUSTRY
First posted: 2022-09-21
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective multicenter study designed to test the feasibility of the 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).

Eligibility criteria: 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

Primary outcomes:
measure: Rate of explants and revisions at 6 months after device activation
timeFrame: 6 months after device activation
measure: Rate of device activation successes
timeFrame: 5 weeks after device implantation
Secondary outcomes:
measure: Number of subjects with 50% reduction or greater in 24-hour pad weight test
timeFrame: 90, 185 and 365 days after activation
measure: Number of subjects with 75% reduction or greater in 24-hour pad weight test
timeFrame: 90, 185 and 365 days after activation
measure: 3-day bladder diary
timeFrame: 90, 185 and 365 days after activation
measure: General quality of life questionnaire
timeFrame: 90, 185 and 365 days after activation
measure: Disease specific questionnaire (level of incontinence)
timeFrame: 90, 185 and 365 days after activation
measure: Disease specific questionnaire (symptoms and quality of life)
timeFrame: 90, 185 and 365 days after activation
measure: Disease specific questionnaire (sexual activity)
timeFrame: 90, 185 and 365 days after activation
measure: Disease specific questionnaire (quality of life)
timeFrame: 90, 185 and 365 days after activation
measure: Disease specific questionnaire (type of incontinence)
timeFrame: 90, 185 and 365 days after activation
measure: Post void residuals
timeFrame: 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
measure: Patient satisfaction
timeFrame: 5 weeks after device implantation (device activation), and 14, 30, 90, 185, 365 and 730 days after activation
measure: Physician satisfaction questionnaire
timeFrame: Within 45 days after baseline (device implantation), 5 weeks after implantation (device activation), and 14, 30, 90, 185, 365 and 730 days after activation
measure: Rate of adverse events
timeFrame: 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
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: Groupe Hospitalier Pitié-Salpêtrière
Study officials:
affiliation: Groupe Hospitalier Pitié-Salpêtrière
name: Emmanuel Chartier-Kastler
role: PRINCIPAL_INVESTIGATOR
References: