LIBERATE International

Viveve

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Device: Viveve Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT03619174

LIBERATE International

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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99 participants in 2 patient groups, including a placebo group

Active Treatment

Active Comparator group

Description:

Treatment dose

Treatment:

Device: Viveve Treatment

Sham Treatment

Placebo Comparator group

Description:

Sub-therapeutic dose

Treatment:

Device: Viveve Treatment