LIBERATE International

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Viveve Treatment


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Treatment<br>Treatment dose | Device: Viveve Treatment<br>* 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.<br>|
| Placebo Comparator: Sham Treatment<br>Sub-therapeutic dose | Device: Viveve Treatment<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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incontinence, urine, urinary, pee, leak, SUI