At a glance
ClinicalIndex Comparison RecordN/ACompleted· 99 enrolled
Drug / intervention
Viveve Treatmentdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
LIBERATE International: Evaluation of the Safety and Efficacy of the Viveve Treatment for Stress Urinary Incontinence
In Brief
A clinical study evaluating Viveve Treatment for Stress Urinary Incontinence. Completed, enrolled 99 participants across 6 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStress Urinary Incontinence
CountriesCanada
Collaborators--
Timeline
N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartAug 2018
Primary CompletionJul 2019
TodayJul 2026
First PostedAug 7, 2018
Enrollment StartAug 8, 2018
Primary CompletionJul 5, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.9 years ago
Interventions
Viveve Treatmentdevice
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.