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

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