Solace Stress Urinary inContinence Control Efficacy and Safety Study

Study Overview
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Brief Summary
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The SUCCESS Trial is designed to determine whether the Solace Bladder Control System is safe and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females.

Detailed Description
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Subject will undergo treatment with the Solace Bladder Control System or a sham procedure, with the results being compared at 3 months. All patients undergoing sham treatment are treated at 3 months.

Official Title
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Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Solace Bladder Control (Vesair) Balloon
* Device: Solace Sham Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 18 years of age or older with stress urinary incontinence (SUI) Experienced SUI for at least 12 months and attempted and failed prior noninvasive treatment Willing to undergo cystoscopic procedures required and 36 month follow-up On stable medication for a minimum of 3 months Free of local genital skin infection Positive Pad Weight Test Free of impassable urethral strictures, trauma or necrosis Exclusion Criteria: Pregnant or planning to become pregnant during the study period Non-ambulatory or bedridden or physically unable to complete test exercises Morbidly obese (defined as BMI ≥ 40 kg/m2) Incontinence of neurogenic etiology Urge predominant Mixed Incontinence Bladder infection (including bladder inflammation or edema) or Urinary Tract Infection (UTI) within 3 months History of recurrent urinary tract infections Prior surgical procedure for incontinence within the past 6 months Is taking medications for urinary incontinence other than anticholinergics History of recurrent (>1) or recent (within 5 years) kidney stone(s) Has a prosthetic heart valve Unable to tolerate any form of antibiotic Taking anticoagulation therapy, other than aspirin Has urinary incontinence due to Intrinsic Sphincter Deficiency (ISD)

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Subjects undergoing treatment with the Solace Bladder Control (Vesair) Balloon on day 0 | Device: Solace Bladder Control (Vesair) Balloon<br>* Subjects may undergo treatment every 12 months until study completion.<br>* Other names: Vesair Balloon;|
| Sham Comparator: Solace Sham Treatment<br>Subjects undergoing sham treatment on day 0, and treatment with the Solace Bladder Control (Vesair) Balloon at 3 months | Device: Solace Bladder Control (Vesair) Balloon<br>* Subjects may undergo treatment every 12 months until study completion.<br>* Other names: Vesair Balloon;Device: Solace Sham Treatment<br>* Sham treatment that resembles treatment with the Solace Bladder Control (Vesair) Balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in quality of life as assessed by pad weight tests assessments and questionnaires | Comparison of increases in pad weight test and patient reported outcomes on questionnaires | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-related adverse events | Site-reported adverse events designated as related to the treatment | 3 Months | 
| Severity of treatment-related adverse events | Site-reported adverse events designated as related to the treatment. | 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress Urinary Incontinence, SUI