LIBERATE International

LIBERATE International: Evaluation of the Safety and Efficacy of the Viveve Treatment for Stress Urinary Incontinence

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: Viveve Treatment

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 Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • LIBERATE In't Site
  • Montreal
    • Pointe-Claire, Montreal, Canada
      • LIBERATE Int'l Site
  • Ontario
    • Burlington, Ontario, Canada
      • LIBERATE Int'l Site
    • London, Ontario, Canada
      • LIBERATE Int'l Site
    • Sarnia, Ontario, Canada
      • LIBERATE Int'l Site
    • Toronto, Ontario, Canada
      • LIBERATE Int'l Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Key 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Treatment; Treatment dose	Device: Viveve Treatment; The Viveve system is a monopolar radiofrequency system that uses surface cooling and radiofrequency (RF) energy delivery to provide a non-surgical and minimally-invasive approach to generate heat within the submucosal layers of vaginal tissue while keeping the surface cool.
Placebo Comparator: Sham Treatment; Sub-therapeutic dose	Device: Viveve Treatment; The Viveve system is a monopolar radiofrequency system that uses surface cooling and radiofrequency (RF) energy delivery to provide a non-surgical and minimally-invasive approach to generate heat within the submucosal layers of vaginal tissue while keeping the surface cool.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CFB in 1-hour Pad Weight Test	Change from baseline in the 1-hour pad weight test to 6 months post-treatment.	6 months post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Adverse Event Reporting	Safety as assessed by Adverse Event reporting	6 months post-treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
UDI-6	Validated urinary incontinence questionnaire titled Urogenital Distress Inventory-6 (UDI-6). UDI-6 contains 6 items about urinary problems. Each item is scored between 0 (no problem) to 3 (bothered greatly). All scores are summed, divided by 18 and then multiplied by 100 for the scale score. Minimum scale score is 0 and maximum is 100. Higher score indicates higher disability. Efficacy measure of change from baseline to 3- and 6- months post-treatment in UDI-6.	6 months post-treatment
ICIQ-UI-SF	Validated urinary incontinence questionnaire titled International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF)	6 months post-treatment
I-QOL	Validated urinary incontinence questionnaire titled Incontinence Quality of Life (I-QOL)	6 months post-treatment
FSFI	Validated questionnaire titled The Female Sexual Function Index (FSFI)	6 months post-treatment
Voiding Episodes Per Day	Voiding episodes per day tracked via daily voiding diary.	6 months post-treatment

Collaborators and Investigators

• Sponsor: Viveve Inc.
• Investigators: Study Director: Stacie Bell, PhD, Viveve Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2018
• Primary Completion (Actual): July 5, 2019
• Study Completion (Actual): July 5, 2019

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 7, 2018

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: urine; incontinence; SUI; leak; urinary; pee
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: LIBERATE International

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes