Vesair Clinical Trial

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