ProACT Post-Approval Study

Inclusion Criteria

• •1. Subject is a male of at least 50 years of age.
• •2. Subject demonstrates stress urinary incontinence.
• •3. Subject has undergone a radical prostatectomy, transurethral resection of the prostate, or other prostate surgery.
• •4. Subject is willing and able to undergo surgical implantation of ProACT devices.
• •5. Subject is willing and able to comply with study-required
• •follow-up activities, including annual telephonic follow -up interviews, for a period of 5 years from their date of initial implantation. This includes compliance even after possible explant of ProACT devices and/or possible implantation of subsequent therapies.
• •6. Subject is willing and able to sign the approved informed consent.
• •7. Subject has two positive 24-hour pad weight tests (greater than or equal to 8 gram pad weight increase demonstrated in two 24-hour pad weight tests).
• •8. Subject has a negative urine culture.
• •9. Subject has no known urogenital malignancy, other than previously treated prostate cancer.
• •10. Subject meets ONE of the following criteria:
• •1. Baseline Prostate-Specific Antigen (PSA) of less than or equal to 2.5ng/mL;
• •2. Baseline PSA \> 2.5ng/mL and less than or equal to 10 ng/mL AND free PSA greater than or equal to 25% of total PSA;
• •11. Physician determines subject to be a suitable surgical candidate.