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Prospective US Radiofrequency SUI Trial

NCT04720352 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2021-07-26

No results posted yet for this study

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.

Conditions

  • Urinary Incontinence, Stress

Interventions

DEVICE

Active treatment

Active treatment delivers radiofrequency and cryogen

DEVICE

Sham

Sham delivers non therapeutic levels of radiofrequency and cryogen

Sponsors & Collaborators

  • Viveve Inc.

    lead INDUSTRY

Principal Investigators

  • Eric S Rovner, MD · Medical University of South Carolina

  • Roger R Dmochowski, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-11
Primary Completion
2022-12-30
Completion
2022-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04720352 on ClinicalTrials.gov