Artificial Urinary Sphincter Clinical Outcomes

• Male

• ≥ 18 years of age

• Has undergone either a radical prostatectomy, transurethral resection of the prostate or other invasive prostate surgery

• Demonstrates primary stress urinary incontinence

• Positive screening 24-hour pad weight test (≥100 grams)

• Experiences at least 3 incontinence episodes per day during baseline diary or presents with continuous incontinence

• Negative urine culture

• Willing and able to undergo surgical implantation of the AUS device

• Willing and able to comply with the follow-up requirements

⁃ Willing and able to forego any other surgical urinary incontinence treatments while participating in the study

⁃ Willing and able to sign the informed consent