Viveve Medical, Inc. announced that it has initiated its multicenter, randomized, double-blinded, sham-controlled trial entitled Prospective U.S. Radiofrequency SUI Trial (PURSUIT). The protocol of the PURSUIT Trial reflects changes to the study design that were approved by the U.S. Food and Drug Administration (FDA) in December 2020, including an increase in size to 390 subjects across 30 U.S. investigational sites and better-defined inclusion/exclusion criteria related to a diagnosis of moderate stress urinary incontinence (SUI) for participants. The study changes are designed to provide a clearer assessment of the trial’s primary endpoint. If positive, results could support a marketing application for a new SUI indication for Viveve’s cryogen-cooled monopolar radiofrequency (CMRF) technology in the U.S. PURSUIT is a randomized, double-blinded, sham-controlled trial with an intended enrollment of 390 subjects with moderate SUI (= 10ml – 50ml urine leakage on the 1-hour Pad Weight Test) at up to 30 study sites in the U.S. Randomized in a 2:1 ratio for active and sham treatments, subjects in the active treatment arm (260 subjects) will receive the CMRF treatment (90J/cm2 RF and cryogen-cooling), while subjects in the control arm (130 subjects) will receive an inert sham treatment. The primary efficacy endpoint of the PURSUIT 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. The study also includes several secondary endpoints, including: proportion of patients who experience greater than 50% reduction in urine leakage on the standardized 1-hour Pad Weight Test at three and six months post-treatment; percentage change from baseline in the 1-hour Pad Weight Test at three, six and 12 months; percent of subjects with no incontinence episodes at 3, 6 and 12 months post-treatment as assessed with the three-day bladder voiding diary; and change from baseline in the MESA Questionnaire (Medical, Epidemiologic and Social Aspects of Aging), Incontinence Quality of Life (I-QOL), Patient Global Impression of Improvement (PGI-1) Questionnaire, and International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) at 3, 6 and 9 months post treatment. Subject safety will be monitored throughout the study.