Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence

Clinical Investigation of an Adjustable Continence Therapy (ACT) Periurethral Prosthetic System for Treatment of Female Stress Urinary Incontinence With or Without Hypermobility

The purpose of this study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 160 implanted female patients in which two adjustable balloons (one on each side of the urethra) are implanted to treat urinary stress incontinence.

The results will be analyzed to demonstrate the effects of the device as well as its associated risks. Therapeutic success will be based on whether the patients demonstrate at least a one-grade (mean) reduction in the Stamey score at 12 months.

This is a multi-center, prospective, non randomized clinical trial comparing baseline data to the 12 month data. Urodynamic testing, pad weights and a direct visual stress test will be used to determine success along with the Stamey score.

Inclusion Criteria:

• Women
• 18 years or older
• Diagnosed with stress urinary incontinence with or without urethral hypermobility
• Willing to sign informed consent
• Candidates for surgical intervention for stress incontinence
• Negative urinalysis or urine culture within 2 weeks of implantation
• Normal cystourethroscopy
• Failed at least 6 months of previous treatments for stress urinary incontinence (e.g., exercise regimen, electrical stimulation, surgical procedures, etc.)
• May have failed suspension or sling procedures

Exclusion Criteria:

• Pregnant or lactating
• Life expectancy of less than one year
• Insulin dependant diabetic
• Auto-immune disease
• Undergoing radiation therapy
• Active urinary tract infection
• Detrusor instability refractory to meds
• Reduced bladder compliance
• Significant bladder residual >100mls
• Bladder cancer
• Unsuccessfully treated bladder stones
• Current urethral stricture preventing the passage of a 24 French endoscope
• Neurogenic bladder
• Uncorrected rectocele, cystocele, urethrocele, enterocele or pelvic prolapse of Grade 3 or higher
• Prior pelvic radiotherapy
• Artificial urinary sphincter implanted