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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Urinary Incontinence

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Open Label Study, ACT (Adjustable Continence Therapy) | Device: ACT (Adjustable Continence Therapy)<br>* surgically implanted device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Stamey Grade From Baseline to 12 Months. | The Stamey grade classifies the severity of stress incontinence in four possible grades from 0-3. Grade 0: no leaking, Grade 1: loss of urine with sudden increases of abdominal pressure: e.g. coughing, sneezing or laughing, Grade 2: loss of urine with lesser degrees of stress: e.g. walking or standing up, and Grade 3: loss of urine without any relation to physical activity or position, e.g. while lying in bed. The primary end point at 12 months is a mean change in Stamey Grade from baseline of greater than or equal to -1. | Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incontinence Quality of Life (IQoL) Questionnaire | Change on Incontinence Quality of Life (IQoL) Questionnaire from baseline to 12 months. 0 being lowest quality of life, 100 being highest quality of life. | Baseline to 12 months | 
| Incontinence Impact Questionnaire (IIQ-7) | Incontinence Impact Questionnaire (IIQ-7) change from baseline to 12 months. Scores range from 0-100. 0 being impact from incontinence, 100 being most impacted from incontinence. | Baseline to 12 months | 
| Urinary Distress Inventory (UDI-6) | Change on Urinary Distress Inventory (UDI-6) questionnaire from baseline to 12 months. 0 being not distressed, 100 being very distressed. | Baseline to 12 months | 
| Number of Incontinence Episodes Per Day (Voiding Diary) | Change in Number of Incontinence Episodes Per Day from baseline to 12 months. 0 being the best. | Baseline to 12 months | 
| Number of Pads Changed Per Day (Voiding Diary) | Change in Number of Pads Changed Per Day from baseline to 12 months. 0 pads changed a day being the best. | Baseline to 12 months | 
| Provocative Pad Weight | Change in weight of pads (gm) from baseline to 12 months. 0 gm pad weight being the best. | Baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary incontinence