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

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: …