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

Study Overview
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Brief Summary
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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.

Official Title
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A Clinical Investigation of the Adjustable Continence Therapy (ACT) for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency

Conditions
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Urinary Incontinence, Urinary Incontinence,Stress

Intervention / Treatment
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* Device: Adjustable Continence Therapy for Women (ACT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective, single arm, non-randomized, multicenter, prospective case-series trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adjustable Continence Therapy for Women<br>Implantation of the Adjustable Continence Therapy for the treatment of female SUI. | Device: Adjustable Continence Therapy for Women (ACT)<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provocative pad weight | Change in provocative pad weight from baseline | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urogenital Distress Inventory (UDI) | Six item questionnaire. Scores range from 0-100. 0 being not distressed, 100 being very distressed. | 12 months | 
| Incontinence Quality of Life Questionnaire (I-QOL) | Twenty-two item questionnaire. Scores range from 0-100. 0 being lowest quality of life, 100 being highest quality of life. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Incontinence, Urination Disorders, Urination Involuntary, Urologic Diseases, Lower Urinary Tract Symptoms