The AttenueX IntraVesical System for the Treatment of Female Stress Urinary Incontinence

Study Overview
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Brief Summary
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Over 11 million women in the United States suffer from stress urinary incontinence (SUI), the involuntary leakage of urine during routine physical activities such as laughing, coughing, exercising, or sneezing. SUI affects women of all ages and can result in significant emotional distress. The purpose of this study is to evaluate a non-surgical, investigational treatment intended to reduce or eliminate urine leakage due to stress urinary incontinence.

Detailed Description
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A multicenter, prospective, randomized, single-blinded, two-arm longitudinal trial of the safety and effectiveness of the AttenueX Device in reducing incontinence. Subjects randomized to the control arm will have the AttenueX Device inserted at the end of the 3-month control period. For those subjects who are randomized to the treatment group, the AttenueX Device will be inserted into the bladder on Day 0, and replaced every 90 days by a new device for nine months. Subjects randomized into the treatment group will be followed for a minimum of 12 months after receiving the AttenueX Device, while subjects randomized into the control group will be followed for 3 months without the AttenueX Device and a minimum of 12 months after receiving the AttenueX Device.

Official Title
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An Evaluation of the AttenueX IntraVesical System in the Management of Female Subjects With Stress Urinary Incontinence

Conditions
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Urinary Incontinence, Stress

Intervention / Treatment
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* Device: AttenueX IntraVesical System
* Procedure: Sham Procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female subjects ≥ 18 years of age Experienced stress urinary incontinence (SUI) for at least 12-months and failed prior non-surgical treatment VLPP ≥ 60cm H20 Stamey Grade ≥ 1 Free of local skin infection, impassable urethral strictures, trauma or necrosis Provide written informed consent Exclusion Criteria: Pregnant or planning pregnancy 3 or more urinary tract infections within previous year Intrinsic sphincter deficiency Incontinence surgery within previous 6-months Cystocele ≥ grade 3 Previous pelvic radiation therapy Presence of urethral abnormalities Recent urosepsis History of interstitial or follicular cystitis Uncontrolled diabetes Biofeedback within previous 3 months Morbid obesity Use of anticoagulants other than aspirin

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: device<br>insertion of balloon system | Device: AttenueX IntraVesical System<br>* Insertion of the Solace AttenueX Intravesical System on Day 0<br>* Other names: Solace Balloon;|
| Sham Comparator: sham<br>cystoscopy with sham system | Device: AttenueX IntraVesical System<br>* Insertion of the Solace AttenueX Intravesical System on Day 0<br>* Other names: Solace Balloon;Procedure: Sham Procedure<br>* Cystoscopy with Simulated Insertion of AttenuEX Intravescial System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stamey Grade |  | 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pad Weight |  | 6-months | 
| VLPP |  | 6-months | 
| I-QOL |  | 6-months | 
| Incontinence Episode Frequency |  | 6-months |