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 theprostate, 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 aperiod of 5 years from their date of initial implantation. This includes complianceeven after possible explant of ProACT devices and/or possible implantation ofsubsequent 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 grampad 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 prostatecancer.

10. Subject meets ONE of the following criteria:

11. Baseline Prostate-Specific Antigen (PSA) of less than or equal to 2.5ng/mL;

12. Baseline PSA > 2.5ng/mL and less than or equal to 10 ng/mL AND free PSA greaterthan or equal to 25% of total PSA;

13. Physician determines subject to be a suitable surgical candidate.

Exclusion Criteria:

1. Subject has an existing urethral stricture, a history of any urethral strictures, orhas ever had a urethrotomy.

2. Subject has undergone prostate surgery or any anti-incontinence surgery within thelast 12 months.

3. Subject has an artificial urinary sphincter or any components of a previouslyimplanted artificial urinary sphincter in vivo.

4. Subject has undergone radiation therapy in the prostatic area within the last 12months.

5. Subject has untreated or unsuccessfully treated detrusor instability orover-activity.

6. Subject has an atonic bladder.

7. Subject had, presently has, or is suspected of having bladder cancer.

8. Subject has untreated or unsuccessfully treated bladder stones.

9. Subject has detrusor sphincter dyssynergia.

10. Subject has known hemophilia or a bleeding disorder.

11. Subject has a known severe contrast solution allergy (e.g., anaphylaxis, cardiac, orrespiratory arrest).

12. Subject has insulin-dependent diabetes that is uncontrolled or not controllable, asindicated by an A1c test result of = 6.5%.