Overview
A prospective, single arm, non-randomized, multicenter, prospective case-series trial. The purpose of this trial is to demonstrate the safety and effectiveness of using the Adjustable Continence Therapy (ACT) to provide a clinically relevant improvement in stress urinary incontinence.
Eligibility
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