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Vesair Pivotal Trial (VAPOR): An Evaluation of the Vesair® Bladder Control System for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women.

Trial ID:
IRB-19-7467
Bruce Kahn
Single-blind, multicenter, randomized clinical trial of the Vesair Balloon in the treatment of Stress Urinary Incontinence in post-menopausal women

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

Why isn't this trial accepting new patients?

The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting

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