LIBERATE International
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03619174 |
Recruitment Status :
Completed
First Posted : August 7, 2018
Last Update Posted : July 26, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stress Urinary Incontinence | Device: Viveve Treatment | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 99 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | LIBERATE International: Evaluation of the Safety and Efficacy of the Viveve Treatment for Stress Urinary Incontinence |
Actual Study Start Date : | July 24, 2018 |
Actual Primary Completion Date : | July 5, 2019 |
Actual Study Completion Date : | July 5, 2019 |

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. |
- CFB in 1-hour Pad Weight Test [ Time Frame: 6 months post-treatment ]Change from baseline in the 1-hour pad weight test
- Safety and Adverse Event Reporting [ Time Frame: 6 months post-treatment ]Safety as assessed by Adverse Event reporting
- UDI-6 [ Time Frame: 3 and 6 months post-treatment ]Validated urinary incontinence questionnaire titled Urogenital Distress Inventory-6 (UDI-6)
- ICIQ-UI-SF [ Time Frame: 3 and 6 months post-treatment ]Validated urinary incontinence questionnaire titled International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF)
- I-QOL [ Time Frame: 3 and 6 months post-treatment ]Validated urinary incontinence questionnaire titled Incontinence Quality of Life (I-QOL)
- FSFI [ Time Frame: 3 and 6 months post-treatment ]Validated questionnaire titled The Female Sexual Function Index (FSFI)
- Voiding Episodes per Day [ Time Frame: 6 months post-treatment ]Voiding episodes per day tracked via daily voiding diary.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619174
Canada, British Columbia | |
LIBERATE In't Site | |
Vancouver, British Columbia, Canada | |
Canada, Montreal | |
LIBERATE Int'l Site | |
Pointe-Claire, Montreal, Canada | |
Canada, Ontario | |
LIBERATE Int'l Site | |
Burlington, Ontario, Canada | |
LIBERATE Int'l Site | |
London, Ontario, Canada | |
LIBERATE Int'l Site | |
Sarnia, Ontario, Canada | |
LIBERATE Int'l Site | |
Toronto, Ontario, Canada |
Study Director: | Stacie Bell, PhD | Viveve Inc. |
Responsible Party: | Viveve Inc. |
ClinicalTrials.gov Identifier: | NCT03619174 |
Other Study ID Numbers: |
LIBERATE International |
First Posted: | August 7, 2018 Key Record Dates |
Last Update Posted: | July 26, 2019 |
Last Verified: | July 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
incontinence urine urinary |
pee leak SUI |
Urinary Incontinence Enuresis Urinary Incontinence, Stress Urination Disorders Urologic Diseases |
Lower Urinary Tract Symptoms Urological Manifestations Behavioral Symptoms Elimination Disorders Mental Disorders |