A Clinical Investigation of the Adjustable Continence Therapy (ACT) for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency
Uromedica
Summary
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
- Age range
- 22+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion 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 sig…
Interventions
- DeviceAdjustable Continence Therapy for Women (ACT)
Two ACT devices are implanted in each patient. The devices are intended for implantation in the paraurethral space, with the balloons located on each side of the urethra near the bladder neck. The ports are placed subcutaneously in the labia majora. The balloons are filled after implantation with an isotonic solution via needle injection into the port. The ACT implant can be placed using local, spinal or general anesthesia with the surgical instruments (provided separately).
Locations (2)
- University of ColoradoDenver, Colorado
- CHI Health Research CenterOmaha, Nebraska