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LIBERATE International

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ClinicalTrials.gov Identifier: NCT03619174
Recruitment Status : Recruiting
First Posted : August 7, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Viveve Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Device: Viveve Treatment Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. CFB in 1-hour Pad Weight Test [ Time Frame: 6 months post-treatment ]
    Change from baseline in the 1-hour pad weight test


Secondary Outcome Measures :
  1. Safety and Adverse Event Reporting [ Time Frame: 6 months post-treatment ]
    Safety as assessed by Adverse Event reporting


Other Outcome Measures:
  1. UDI-6 [ Time Frame: 3 and 6 months post-treatment ]
    Validated urinary incontinence questionnaire titled Urogenital Distress Inventory-6 (UDI-6)

  2. 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)

  3. I-QOL [ Time Frame: 3 and 6 months post-treatment ]
    Validated urinary incontinence questionnaire titled Incontinence Quality of Life (I-QOL)

  4. FSFI [ Time Frame: 3 and 6 months post-treatment ]
    Validated questionnaire titled The Female Sexual Function Index (FSFI)

  5. Voiding Episodes per Day [ Time Frame: 6 months post-treatment ]
    Voiding episodes per day tracked via daily voiding diary.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
Contact: Marisol Clemens 720-696-8100 mclemens@viveve.com

Locations
Canada
LIBERATE Intl Site Recruiting
Burlington, Canada
LIBERATE Intl Site Not yet recruiting
Calgary, Canada
LIBERATE Intl Site Not yet recruiting
London, Canada
LIBERATE Intl Site Recruiting
London, Canada
LIBERATE Intl Site Recruiting
Pointe-Claire, Canada
LIBERATE Intl Site Recruiting
Sarnia, Canada
LIBERATE Int Site Recruiting
Vancouver, Canada
Sponsors and Collaborators
Viveve Inc.
Investigators
Study Director: Stacie Bell, PhD Viveve Inc.
More Information
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Responsible Party: Viveve Inc.
ClinicalTrials.gov Identifier: NCT03619174     History of Changes
Other Study ID Numbers: LIBERATE International
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Viveve Inc.:
incontinence
urine
urinary
 pee
leak
SUI

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
 Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders