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Vesair® Bladder Control Balloon Procedure for Stress Urinary Incontinence
Bruce Kahn, M.D.
This study is evaluating the safety and effectiveness of an investigational balloon device for treating stress urinary incontinence (SUI) in post-menopausal women who have tried and failed conservative treatment such as Kegel exercises or pelvic floor muscle training. The device addresses the underlying cause of SUI: the inability of the bladder to store urine during everyday physical activities without sudden increases in pressure.
Be available for minimum study duration of 12 months and maximum study duration of up to 36 months
Be postmenopausal female at least 18 years of age
Have symptoms of stress urinary incontinence (SUI) for at least 12 months
Patients must not:
Have a urinary tract infection in the past 3 months
Have 2 or more urinary tract infections in the past 12 months
Have blood clots in the urine
Be on systemic hormone replacement therapy
Be taking duloxetine (Cymbalta) or imipramine (Tofranil)
Be taking blood thinners on a regular basis (other than aspirin)
Have had surgery for incontinence in past 6 months
Have Parkinson's disease or multiple sclerosis
Have any kidney stones within past 5 years
Be bedridden or physically unable to perform moderate activities for at least 30 minutes, including walking, climbing stairs, and moving a small 15 lb. weight from one chair to another
Have a BMI greater than or equal to 40
The Vesair® balloon is a small, lightweight device that floats within the bladder and is designed to reduce involuntary urinary leakage during physical activity. It acts as a shock absorber to reduce temporary pressure changes in the bladder that causes urinary leakage.