VIVE - Viveve Medical launches pivotal study of RF treatment for urinary incontinence

Nano-cap Viveve Medical ([[VIVE]] +1.9%) has initiated its pivotal PURSUIT Trial to evaluate cryogen-cooled monopolar radiofrequency ((CMRF)) in stress urinary incontinence. The protocol of trial reflects changes to the study design approved by the FDA, including an increase in size to 390 subjects, to provide a clearer assessment of the trial's primary endpoint.Primary efficacy endpoint of the Trial is a comparison of the proportion of patients who experience greater than 50% reduction in urine leakage compared to baseline on the standardized 1-hour Pad Weight Test at 12 months post-treatment versus the new sham procedure.Enrollment is expected to complete by the end of the second quarter of this year.The company announced positive results from a 36-subject three-arm feasibility study evaluating its CMRF for the treatment of mild-to-moderate stress urinary incontinence in women, in August last year.

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Viveve Medical launches pivotal study of RF treatment for urinary incontinence