RANDOMIZED PLACEBO-CONTROLLED SINGLE BLINDED MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF YONI.FIT IN WOMEN WITH STRESS URINARY INCONTINENCE (SUI)

Brief description of study

This study will look at how safe and how well the investigational device, Yo¯ni.Fit® device works in improving the symptoms of stress urinary incontinence (SUI). Stress urinary incontinence is a condition in which accidental and unintentional urine leaks happen during exercising, laughing, coughing, dancing, sneezing, or any physical activities that puts pressure on your bladder. Stress incontinence is not related to psychological stress. Yo¯ni.Fit® Bladder Support is an investigational device because it has not been approved by the U.S. Food and Drug Administration (FDA). Yo¯ni.Fit® Bladder Support is an intra-vaginal (placed in the vagina) device made with soft medical grade silicone (latex free and BPA free), which will be used for 12 hours per day as a temporary management for stress urinary incontinence.


Clinical Study Identifier: s18-02041
ClinicalTrials.gov Identifier: NCT03978741
Principal Investigator: Nirit Rosenblum.


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