NCT04720352

Prospective US Radiofrequency SUI Trial

PURSUIT: Prospective US Radiofrequency SUI Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 390 (estimated)
• Sponsor: Viveve Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Urinary Incontinence, Stress

Interventions

Type	Name	Description
DEVICE	Active treatment	Active treatment delivers radiofrequency and cryogen
DEVICE	Sham	Sham delivers non therapeutic levels of radiofrequency and cryogen

Timeline

• Start date: 2021-01-11
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2021-01-22
• Last updated: 2021-07-26

Locations

29 sites across 1 country: United States

Regulatory

• FDA-regulated device study