NCT Number: NCT03619174
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
LIBERATE In't Site, Vancouver, British Columbia, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Exclusion criteria
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.
Time frame: 6 months post-treatment
Change from baseline in the 1-hour pad weight test to 6 months post-treatment.
Time frame: 6 months post-treatment
Safety as assessed by Adverse Event reporting
Time frame: 6 months post-treatment
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.
Time frame: 6 months post-treatment
Validated urinary incontinence questionnaire titled International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF)
Time frame: 6 months post-treatment
Validated urinary incontinence questionnaire titled Incontinence Quality of Life (I-QOL)
Time frame: 6 months post-treatment
Validated questionnaire titled The Female Sexual Function Index (FSFI)
Time frame: 6 months post-treatment
Voiding episodes per day tracked via daily voiding diary.
Viveve Inc.
Industry
LIBERATE International: Evaluation of the Safety and Efficacy of the Viveve Treatment for Stress Urinary Incontinence
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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