NCT03619174

LIBERATE International

Completed NA Results posted Last updated 21 September 2022

What this trial tests

NA trial testing Viveve Treatment in Stress Urinary Incontinence in 99 participants. Completed in 5 July 2019.

Timeline

8 August 2018

Primary endpoint
5 July 2019

5 July 2019

Quick facts

Lead sponsor	Viveve Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	99
Start date	8 August 2018
Primary completion	5 July 2019
Estimated completion	5 July 2019
Sites	6 locations across Canada

Drugs / interventions tested

• Viveve Treatment

Conditions studied

• Stress Urinary Incontinence — all drugs for Stress Urinary Incontinence →

Sponsor

Viveve Inc.

Who can join

18 and older, female only, with Stress Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

CFB in 1-hour Pad Weight Test Primary · 6 months post-treatment

Change from baseline in the 1-hour pad weight test to 6 months post-treatment.

Group	Value	95% CI
Active	-8.1	-18.5 – -5.7
Sham	-8.1	-16.6 – -4.4

Safety and Adverse Event Reporting Secondary · 6 months post-treatment

Safety as assessed by Adverse Event reporting

Group	Value	95% CI
Active	24
Sham	14

UDI-6 Secondary · 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.

Group	Value	95% CI
Active	-22.2	-38.9 – -5.6
Sham	-16.7	-33.3 – -5.6

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment Emergent Adverse Events reporting occurred from the treatment procedure to study completion (up to 6 months post treatment) for each subject.. Reporting threshold: 4%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active Treatment

Serious: 2/66 (3%)

Deaths: 0/66

Sham Treatment

Serious: 1/33 (3%)

Deaths: 0/33

Serious adverse events (3 terms)

Reaction	System	Active Treatment	Sham Treatment
Right Ankle Fracture	Injury, poisoning and procedural complications	—	—
Angina Pectoris	Cardiac disorders	—	—
Freeman-Sheldon Syndrome	Congenital, familial and genetic disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Active Treatment	Sham Treatment
Abdominal Pain	Gastrointestinal disorders	—	—

Most-reported serious reactions: Right Ankle Fracture, Angina Pectoris, Freeman-Sheldon Syndrome.

Data from ClinicalTrials.gov NCT03619174 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.