Multicenter, prospective, single-arm study to assess the safety and efficacy of the Vesair Bladder Control treatment in post-menopausal women with Stress Urinary Incontinence (SUI) with follow-up at 1, 3 and 12 months. All subjects will be prospectively treated after the subject has provided informed consent and determination that all study entry criteria have been met.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Treatment with Vesair Balloon for one year
WomanCare
Arlington Heights, Illinois, United States
Regional Urology
Shreveport, Louisiana, United States
Chesapeake Urology
Hanover, Maryland, United States
Chesapeake Urology
Owings Mills, Maryland, United States
Provocative Pad Weight
in-office Pad weight test
Time frame: 3 months
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Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States
Women and Infants dept of Urogynecology
Providence, Rhode Island, United States
Urology of Virginia
Virginia Beach, Virginia, United States
Washington Urology
Kirkland, Washington, United States