Study ID: NCT03082118
This study is for postmenopausal women who have been diagnosed with unexpected bladder leaks, also known as stress urinary incontinence (SUI). SUI occurs when abdominal pressure pushes on the bladder during physical activity causing urine to leak.
All women enrolled will be treated with the Vesair Bladder Control System, a small, lightweight balloon (about the size of a quarter) that floats within the bladder. The balloon is designed to eliminate or reduce involuntary urinary leakage. It acts as a “cushion” to reduce the temporary pressure changes in the bladder that cause urinary leakage.
All enrollees will be followed for a maximum of 3 years, with balloon replacement annually.
This interventional study is for women diagnosed with SUI. There is one single arm assignment. All women enrolled are treated.
- Post-menopausal women with SUI or stress predominant mixed incontinence
- Maximum score on IQOL of 60
- Positive cough test for leakage
- Free from infection
- Have previously tried (and failed) noninvasive treatment for SUI
Partial list of exclusion criteria (please see full list of exclusions on clinicaltrials.gov):
- Two or more UTIs in past year and one in past three months
- Surgery for SUI in the past six months
- Grade 3 or worse cystocele
- Last menstrual period within 12 months
- Oral progesterone or estrogen in the past 12 months
- BMI > 40
- Previous incidence of cancer
- Anticoagulation therapy other than aspirin
- Must have been diagnosed with SUI
- Must be willing to have the Vesair Bladder Control balloon inserted into their urinary bladder and replaced annually for three years