A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)

Prospective, multicenter, single-arm study

Key Inclusion Criteria: * Male subjects aged ≥ 22 years old * Able to read, comprehend and willing to sign an informed consent form * Primary diagnosis of stress urinary incontinence for at least 6 months, as assessed by the investigator * Appropriate surgical candidate with no medical or mental condition that would interfere with study procedures or confound study outcomes as assessed by the investigator Key Exclusion Criteria: * Currently enrolled or plans to enroll in another investigational device or clinical drug trial or has completed an investigational study (for urinary incontinence) in the past 3 months prior to informed consent * Poor candidate for surgical procedures and/or anesthesia, as determined by investigator * Currently implanted with an Active Implantable Medical Device (AIMD) * Symptoms or diagnosis of urge incontinence or mixed incontinence (MI) with a predominant urgency component, as assessed by the investigator