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

Inclusion Criteria

• Female at least 22 years old
• Diagnosed with stress urinary incontinence with primary Intrinsic Sphincter Deficiency
• Provocative pad weight of greater than 11.0 grams
• Candidate for surgical intervention
• Negative urinalysis
• Normal cystourethroscopy
• 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)
• Willing and able to sign informed consent and comply with trial follow-up requirements

Exclusion Criteria

• Pregnant or lactating
• Life expectancy of less than 5 years
• Has uncontrolled diabetes as evidenced by HbA1c over 6.5% and fasting plasma glucose over 130 mg/dL
• Has auto-immune disease
• Undergoing radiation therapy
• Active urinary tract infection
• Detrusor instability refractory to medication
• Reduced bladder compliance as defined by a cystometrogram
• 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
• Has, had, or is suspected of having bladder cancer
• History of bladder stones
• Urethral stricture evidenced during cystourethroscopy
• Has a neurogenic bladder that is atonic or has detrusor sphincter dyssynergia
• Has a diathesis, hemophilia, or a bleeding disorder
• Has a rectocele, cystocele, urethrocele, enterocele, or pelvic prolapse of grade 3 or higher
• Had prior pelvic radiotherapy
• Had a prior artificial urinary sphincter implanted
• Has a neurogenic condition known to affect bladder/sphincter function