Vesair Continued Access Trial

Vesair Continued Access Trial: Use of the Vesair® Bladder Control System in the Treatment of Post-Menopausal Female Subjects With Stress Urinary Incontinence

Single arm study of the Vesair Balloon in postmenopausal women.

All women enrolled will be treated with the vesair balloon and followed for a maximum of 3 years, with balloon replacement annually.

Inclusion Criteria:

• Post-menopausal women with SUI or stress predominant mixed incontinence
• Maximum score on IQOL of 60
• Positive cough test for leakage
• Willing to undergo procedures
• Free from infection
• Have previously tried (and failed) noninvasive treatment for SUI

Exclusion Criteria:

• SUI due to SUI
• Urge-predominant mixed incontinence
• Incontinence of neurogenic etiology
• 2 or more UTIs in past year and 1 in past 3 months
• Surgery for SUI in the past 6 months
• taking medication that can be used to treat SUI
• taking medication that affects urinary symptoms for less than 3 months
• undergoing biofeedback
• Grade 3 or worse cystocele
• last menstrual period within 12 months
• oral progesterone or estrogen in the past 12 months
• BMI > 40
• involuntary detrusor contractions or discomfort during bladder filling
• previous stage III or worse cancer
• previous cancer of the urinary tract
• previous symptoms for early stage cancer in the past 2 years
• anticoagulation therapy other than aspirin
• history of prosthetic heart valve
• neurological or connective tissue condition or disease affecting bladder function
• known allergy to device components