Clinical Investigation of the ProACT Adjustable Continence Therapy for Treatment of Post-Prostatectomy Stress Urinary Incontinence

Inclusion Criteria:

- Undergone either a radical prostatectomy, transurethral resection of the prostate or
other prostate surgery at least 12 months prior without radiation therapy

- Demonstrate primary stress urinary incontinence

- Male subjects at least 45 years of age

- Willing and able to undergo surgical implantation of the ProACT devices

- 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

- Positive 24 hour pad weight tests (greater than or equal to 8 gram pad weight
increase demonstrated in two 24-hour pad weight tests)

- Experiences at least 3 incontinence episodes per day during two baseline voiding
diaries.

- Negative Urine culture

- No recurrent stricture at the anastamosis

- No known urogenital malignancy other than previously treated prostate cancer

- Physician determines subject to be suitable surgical candidate

Exclusion Criteria:

- Primarily Urge incontinence

- Detrusor instability or over-activity

- Residual volume greater that 100 ml or greater than 25% of the total bladder capacity
after voiding.

- Subject has/had or is suspected of having bladder cancer

- History of recurrent bladder stones

- Neurogenic bladder that is atonic or has detrusor sphincter dyssynergia

- Known hemophilia or a bleeding disorder

- Abnormal PSA, according to sites laboratory standards, unless further investigation
confirms no underlying prostate malignancy.

- Known sever contrast solution allergy

- Has a genitourinary mechanical prosthesis other than previous sling procedure (e.g.,
Artificial Urinary sphincter, implantable penile prosthesis)

- Has a urethral stricture that prevents passage of an 18 F cystoscope or has had more
than one urethrotomy

- Undergone bulking procedure within 6 months of the baseline assessment

- Subject is currently enrolled or plans to enroll in another device or drug clinical
trial.

- Subject is currently using an indwelling catheter or condom catheter for treatment of
incontinence and is not willing to discontinue use at least 4 weeks prior to baseline
assessment.