Urinary Incontinence, Stress Clinical Trial
Official title:
PURSUIT: Prospective US Radiofrequency SUI Trial
PURSUIT: Prospective US Radiofrequency SUI Trial (VI-17-06) is a prospective, randomized, sham controlled, double blind study in premenopausal women with stress urinary incontinence. The study will be conducted in 390 subjects, randomized 2:1 with active or sham treatment. Study duration is 12 months post treatment. The primary objective is to evaluate the efficacy of the Viveve treatment, SUI protocol, in improving mild to moderate stress urinary incontinence (SUI), assessed using the 1-hour Pad Weight Test for up to 12 months post-treatment.
PURSUIT: Prospective US Radiofrequency SUI Trial (VI-17-06) is a prospective, randomized, sham controlled, double blind study in premenopausal women with stress urinary incontinence. The study will be conducted in 390 subjects, randomized 2:1 with active or sham treatment. Study duration is 12 months post treatment. The primary objective is to evaluate the efficacy of the Viveve treatment, SUI protocol, in improving mild to moderate stress urinary incontinence (SUI), assessed using the 1-hour Pad Weight Test for up to 12 months post-treatment. Secondary endpoints include: - Percent of subjects who are responders in the 1-hour Pad Weight Test at 3- and 6-months post-treatment. - Change from Baseline (CFB) to 3, 6- and 12-months post-treatment in the number of incontinence episodes as assessed by the 3-day bladder voiding diary. - Percent of subjects with no incontinence episodes at 3, 6- and 12-months post-treatment as assessed by the 3-day bladder voiding diary. - CFB to 3, 6, 9- and 12-months post-treatment in the I-QOL, ICIQ-UI-SF, PGI-I and MESA questionnaires. - Percent CFB to 3, 6- and 12-months post-treatment in the 1-hour Pad Weight Test. ;
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