Comparison of the Viveve Treatment and Cryogen-Only Treatment Versus Sham Treatment for Stress Urinary Incontinence

NCT ID: NCT04206085

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2020-08-30

Brief Summary

This is a prospective, randomized, single-blind, study comparing both the Viveve Treatment (RF plus cryogen) and cryogen alone treatment versus sham treatment in patients with mild to moderate stress urinary incontinence.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active treatment

Radiofrequency and Cryogen

Group Type: EXPERIMENTAL

Viveve - Active

Intervention Type: DEVICE

Radiofrequency and Cryogen-Cooling

Cryogen-Only

Crygen-Only

Group Type: ACTIVE_COMPARATOR

Viveve - Cryogen-Alone

Intervention Type: DEVICE

Cryogen-Cooling

Sham

Sham comparator

Group Type: SHAM_COMPARATOR

Viveve - Sham

Intervention Type: DEVICE

Sham

Interventions

Viveve - Active

Radiofrequency and Cryogen-Cooling

Intervention Type: DEVICE

Viveve - Cryogen-Alone

Cryogen-Cooling

Intervention Type: DEVICE

Viveve - Sham

Sham

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Pre-menopausal females, ≥ 18 years of age. Premenopausal is defined as a woman who has had menstrual cycles over the previous 12 months.
• Subjects with a BMI of ≤ 35 kg/m².
• 1-hr pad weight at Baseline with a 5 to 50 g net increase from the pre-test pad weight

Exclusion Criteria

• Subjects who are currently breastfeeding or have discontinued breastfeeding fewer than 6 months prior to screening.
• Subjects who are pregnant or plan to become pregnant during the course of the study.
• Subjects who have undergone other stress urinary incontinence treatments, excluding behavioral modifications (e.g., Kegel exercises).
• Has any implantable electrical device [e.g., implantable pacemaker, automatic implantable cardioverter-defibrillator (AICD)].
• Subjects who have started or changed dose of local vaginal hormones <6 weeks before Screening.
• Subjects who have started pelvic floor physical therapy within the last 3 months.
• Undergone previous elective surgical or non-invasive procedure(s) in the vaginal canal (including the Viveve Treatment or any other genital radiofrequency treatment; injectable bulking agent, cosmetic, laser, surgical, and/or genital enhancement procedure, and previous dilation and cuterage within 12 months of the subject's Pre-Screening Visit).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Viveve Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Milestone Research

London, Ontario, Canada

Bluewater Clinical Research Group

Sarnia, Ontario, Canada

Devonshire Clinical Research

Woodstock, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

VI-19-01

Identifier Type: -

Identifier Source: org_study_id