Adjustable Continence Therapy (ACT) for the Treatment of Female SUI

Inclusion Criteria:

1. Female at least 22 years old

2. Diagnosed with stress urinary incontinence with primary Intrinsic SphincterDeficiency

3. Provocative pad weight of greater than 11.0 grams

4. Candidate for surgical intervention

5. Negative urinalysis

6. Normal cystourethroscopy

7. Failed at least 6 months of previous treatment(s) for stress urinary incontinence (e.g., exercise regimen, electrical stimulation, surgical procedures, etc). Note:patients may have failed prior anti-incontinence procedures for SUI (e.g.,suspension, sling, or urethral bulking agent)

8. Willing and able to sign informed consent and comply with trial follow-uprequirements

Exclusion Criteria:

1. Pregnant or lactating

2. Life expectancy of less than 5 years

3. Has uncontrolled diabetes as evidenced by HbA1c over 6.5% and fasting plasma glucoseover 130 mg/dL

4. Has auto-immune disease

5. Undergoing radiation therapy

6. Active urinary tract infection

7. Detrusor instability refractory to medication

8. Reduced bladder compliance as defined by a cystometrogram

9. Significant residual volume (greater than 100 ml) after voiding in which detrusorcontraction is weak, when the bladder volume is greater than or equal to 250 ml

10. Has, had, or is suspected of having bladder cancer

11. History of bladder stones

12. Urethral stricture evidenced during cystourethroscopy

13. Has a neurogenic bladder that is atonic or has detrusor sphincter dyssynergia

14. Has a diathesis, hemophilia, or a bleeding disorder

15. Has a rectocele, cystocele, urethrocele, enterocele, or pelvic prolapse of grade 3or higher

16. Had prior pelvic radiotherapy

17. Had a prior artificial urinary sphincter implanted

18. Has a neurogenic condition known to affect bladder/sphincter function