LIBERATE International

NCT03619174 | Completed Results DMC FDA Device

• 1 other identifier: LIBERATE International
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Stress Urinary Incontinence

Keywords

incontinence; urine; urinary; pee; leak; SUI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety and Adverse Event Reporting

  6 months post-treatment

Other Outcomes (5)

• UDI-6

  6 months post-treatment

• ICIQ-UI-SF

  6 months post-treatment

• I-QOL

  6 months post-treatment

Study Arms (2)

Active Treatment

ACTIVE COMPARATOR

Treatment dose

Device: Viveve Treatment

Sham Treatment

PLACEBO COMPARATOR

Sub-therapeutic dose

Device: Viveve Treatment

Interventions

Viveve Treatment DEVICE

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.

Active Treatment; Sham Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated ICF
• Pre-menopausal females
• Documented diagnosis of SUI

You may not qualify if:

• Pregnant or planning to become pregnant within the year
• Undergone other SUI treatments (excluding Kegels)

Sponsors & Collaborators

• Viveve Inc.: lead

Study Sites (6)

LIBERATE In't Site

Vancouver, British Columbia, Canada

Location

LIBERATE Int'l Site

Pointe-Claire, Montreal, Canada

Location

LIBERATE Int'l Site

Burlington, Ontario, Canada

Location

LIBERATE Int'l Site

London, Ontario, Canada

Location

LIBERATE Int'l Site

Sarnia, Ontario, Canada

Location

LIBERATE Int'l Site

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Toxemia

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections

Results Point of Contact

• Title: Vice President, Clinical & Medical Affairs
• Organization: Viveve

clinicalaffairs@viveve.com

720-696-8173

Study Officials

• Stacie Bell, PhD

  Viveve Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 7, 2018
• Study Start: August 8, 2018
• Primary Completion: July 5, 2019
• Study Completion: July 5, 2019
• Last Updated: September 21, 2022
• Results First Posted: August 18, 2022

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)