Viveve Medical, Inc. Announces Initiation of Pivotal U.S. Pursuit Trial in Stress Urinary Incontinence
January 21, 2021 at 07:00 pm IST
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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.
Viveve Medical, Inc. designs, develops, manufactures and markets a platform medical technology, Cryogen-cooled Monopolar RadioFrequency (CMRF). The Companyâs CMRF technology is delivered through a radiofrequency generator, handpiece and treatment tip, which collectively, is referred to as the Viveve System. The Viveve System is marketed for the non-invasive treatment of vaginal introital laxity, sexual function, vaginal rejuvenation, and stress urinary incontinence (SUI). In the United States, the Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis. The Viveve System is cleared for marketing in approximately 48 countries throughout the world, including North America, Asia Pacific, Europe, the Middle East and Latin America countries. The Companyâs wholly owned subsidiaries include Viveve, Inc. and Viveve BV.