Vesair Clinical Trial

Study Overview
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Brief Summary
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Single-blind, multicenter, randomized clinical trial of the Vesair Balloon in the treatment of Stress Urinary Incontinence in post-menopausal women

Official Title
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An Evaluation of the Vesair® Bladder Control System for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Vesair Balloon
* Other: Sham balloon placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-menopausal women with SUI for at least 12 months Average of at least one leak per day Failed non-invasive treatment Willing to undergo cystoscopy and a minimum of 5 visits over one year Exclusion Criteria: BMI > 40.0 Last menstrual period within 12 months of enrollment On birth control and/or oral hormone replacement therapy Urge-predominant mixed incontinence SUI due to intrinsic sphincter deficiency Prior treatment with the Vesair Balloon Prior medical, surgical or non-surgical treatment for SUI within 6 months of enrollment Recurrent or recent (within the past 5 years) kidney stones Recurrent or recent (within the past 3 months) Urinary Tract Infection Stage 3 or higher cystocele (POP-Q) Interstitial or follicular cystitis / painful bladder syndrome Local genital infection Artificial sphincter Anatomic abnormalities which would interfere with device placement. Visible blood in the urine Uncontrolled bladder contractions / discomfort with bladder filling up to 300cc History of cancer of the urinary tract History of any cancer within the past two years (excluding non-melanoma skin cancers) History of any cancer not (yet) treated with curable intent (excluding non-melanoma skin cancers) Immunologically suppressed or immunocompromised Undergoing pelvic radiation, pelvic fibrosis from previous pelvic radiation Non ambulatory / unable to do simple pad weight testing exercises On anticoagulation therapy with the exception of aspirin History of mental illness requiring inpatient treatment Neurological disease such as Parkinson's or multiple sclerosis Uncontrolled diabetes (A1C > 9%) Recent alcohol or drug abuse requiring treatment in the past year Autoimmune or connective tissue disorders such as Marfan syndrome, Ehlers-Danlos or Myasthenia Gravis Allergy to polyurethane or perfluorocarbons

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vesair<br>Subjects are treated with Vesair Balloon at enrollment (day 0) | Device: Vesair Balloon<br>* Indwelling, intravesical balloon<br>|
| Sham Comparator: Sham<br>Subjects are treated with sham at enrollment (day 0) and treated with balloon (if desired) after six month visit. | Device: Vesair Balloon<br>* Indwelling, intravesical balloon<br>Other: Sham balloon placement<br>* Sham balloon placement procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Endpoint | Pad weight + I-QOL | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pad Weight | Reduction in pad weight | 6 months | 
| I-QOL | Improvement in I-QOL score (0-100 point scale, 100 being the best outcome) | 6 months | 
| Episode Frequency | Reduction in episode frequency as reported on a 7 day diary | 6 months | 
| Patient Global Impression of Improvement (PGI-I) | Significant Improvement per PGI-I (response of very much better or much better on 7 point scale) | 6 months | 

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