Clinical Investigation to Assess a New Artificial Urinary Sphincter to Treat Urinary Incontinence… (NCT05547672) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical Investigation to Assess a New Artificial Urinary Sphincter to Treat Urinary Incontinence in Men
France6 participantsStarted 2022-08-31
Plain-language summary
Prospective multicenter study designed to test the feasibility of the UroMems Artificial Urinary Sphincter.
Who can participate
Age range18 Years
SexMALE
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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 devic…
What they're measuring
1
Rate of explants and revisions at 6 months after device activation