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

Eligibility Criteria

• 1. Female at least 22 years old
• 2. Diagnosed with stress urinary incontinence with primary Intrinsic Sphincter Deficiency
• 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-up requirements
• 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 glucose over 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 detrusor contraction 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 3 or 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