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Vesair® Bladder Control Balloon Procedure for Stress Urinary Incontinence

Trial ID:
IRB-19-7467
Bruce Kahn, M.D.
This study is evaluating the safety and effectiveness of an investigational balloon device for treating stress urinary incontinence (SUI) in post-menopausal women who have tried and failed conservative treatment such as Kegel exercises or pelvic floor muscle training. The device addresses the underlying cause of SUI: the inability of the bladder to store urine during everyday physical activities without sudden increases in pressure.

Inclusion Criteria

Patients must:
  • Be available for minimum study duration of 12 months and maximum study duration of up to 36 months
  • Be postmenopausal female at least 18 years of age
  • Have symptoms of stress urinary incontinence (SUI) for at least 12 months

Exclusion Criteria

Patients must not:
  • Have a urinary tract infection in the past 3 months
  • Have 2 or more urinary tract infections in the past 12 months
  • Have blood clots in the urine
  • Be on systemic hormone replacement therapy
  • Be taking duloxetine (Cymbalta) or imipramine (Tofranil)
  • Be taking blood thinners on a regular basis (other than aspirin)
  • Have had surgery for incontinence in past 6 months
  • Have Parkinson's disease or multiple sclerosis
  • Have any kidney stones within past 5 years
  • Be bedridden or physically unable to perform moderate activities for at least 30 minutes, including walking, climbing stairs, and moving a small 15 lb. weight from one chair to another
  • Have a BMI greater than or equal to 40

Additional Info

  • The Vesair® balloon is a small, lightweight device that floats within the bladder and is designed to reduce involuntary urinary leakage during physical activity. It acts as a shock absorber to reduce temporary pressure changes in the bladder that causes urinary leakage.

Contact Info:

  • Clinical Research Services
  • CRSLeadership@scrippshealth.org