LIBERATE International

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03619174
• Other study ID #: LIBERATE International
• Status: Completed
• Phase: N/A
• Start date: August 8, 2018
• Est. completion date: July 5, 2019

Study information

• Verified date: July 2019
• Source: Viveve Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: July 5, 2019
• Est. primary completion date: July 5, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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.

Locations

Country	Name	City	State
Canada	LIBERATE Int'l Site	Burlington	Ontario
Canada	LIBERATE Int'l Site	London	Ontario
Canada	LIBERATE Int'l Site	Pointe-Claire	Montreal
Canada	LIBERATE Int'l Site	Sarnia	Ontario
Canada	LIBERATE Int'l Site	Toronto	Ontario
Canada	LIBERATE In't Site	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Viveve Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	I-QOL	Validated urinary incontinence questionnaire titled Incontinence Quality of Life (I-QOL)	6 months post-treatment
Other	FSFI	Validated questionnaire titled The Female Sexual Function Index (FSFI)	6 months post-treatment
Other	Voiding Episodes Per Day	Voiding episodes per day tracked via daily voiding diary.	6 months post-treatment
Primary	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	Safety and Adverse Event Reporting	Safety as assessed by Adverse Event reporting	6 months post-treatment