Vesair Continued Access Trial

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