Prospective, multicenter, single-arm study
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
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
Single group
Artificial Urinary Sphincter (AUS)
DeviceAUS implant
Responder rate at 26 weeks post-activation
Proportion of subjects who report greater than or equal to 50% reduction in the 24 hour Pad Weight Test (PWT) at 26 weeks compared with Baseline
Proportion of subjects reporting change in overall impression of improvement (PGI-I)
Proportion of subjects reporting change in their overall impression of improvement with the use of their treatment as compared with Baseline
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