LIBERATE International

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Device: Viveve Treatment

• Registration Number: NCT03619174
• Lead Sponsor: Viveve Inc.

Brief Summary

This is a prospective, randomized, double-blind, sham-controlled clinical study. The study is designed to demonstrate that active is superior to sham for the efficacy endpoints and is deemed to have appropriate safety as compared to sham.

Detailed Description

Approximately ninety-nine (99) subjects meeting the inclusion/exclusion criteria will be randomized in a 2:1 ratio to either the active or sham group. Randomization will be stratified by study site, with a maximum of 21 subjects randomized in an individual site. Subjects will be followed up with at 10 days and at 3 and 6 months post-treatment. Subjects will be assessed for adverse events at all study contacts and visits from the time the informed consent is signed.

Study Timeline

• Study First Submitted: 2018-07-26
• Study First Submitted QC: 2018-08-01
• Study First Posted: 2018-08-07
• Study Start: 2018-08-08
• Status Verified: 2019-07
• Primary Completion: 2019-07-05
• Study Completion: 2019-07-05
• Results First Submitted: 2022-05-12
• Results First Submitted QC: 2022-07-25
• Results First Posted: 2022-08-18
• Last Update Submitted: 2022-08-25
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 99

Inclusion Criteria

• Signed and dated ICF
• Pre-menopausal females
• Documented diagnosis of SUI

Exclusion Criteria

• Pregnant or planning to become pregnant within the year
• Undergone other SUI treatments (excluding Kegels)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Treatment	Viveve Treatment	Treatment dose
Sham Treatment	Viveve Treatment	Sub-therapeutic dose

Primary Outcome Measures

Name	Time	Method
CFB in 1-hour Pad Weight Test	6 months post-treatment	Change from baseline in the 1-hour pad weight test to 6 months post-treatment.

Secondary Outcome Measures

Name	Time	Method
Safety and Adverse Event Reporting	6 months post-treatment	Safety as assessed by Adverse Event reporting

Trial Locations

Locations (2)

LIBERATE Int'l Site; 🇨🇦 Toronto, Ontario, Canada

LIBERATE In't Site; 🇨🇦 Vancouver, British Columbia, Canada