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

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: Viveve - Active; Device: Viveve - Cryogen-Alone; Device: Viveve - Sham

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada
      • Milestone Research
    • Sarnia, Ontario, Canada
      • Bluewater Clinical Research Group
    • Woodstock, Ontario, Canada
      • Devonshire Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active treatment; Radiofrequency and Cryogen	Device: Viveve - Active; Radiofrequency and Cryogen-Cooling
Active Comparator: Cryogen-Only; Crygen-Only	Device: Viveve - Cryogen-Alone; Cryogen-Cooling
Sham Comparator: Sham; Sham comparator	Device: Viveve - Sham; Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-hour Pad Weight Test	Brief description of test: Subject puts on one standardized, pre-weighed pad without voiding.; Subject drinks 500 mL of sodium-free liquid in < 15 min while sitting or resting.• 15 - 45 Minutes:; Subject walks for 30 minutes, including climbing one flight of stairs (up and down).• 45 - 60 Minutes:; Subject performs the following activities Standing up from sitting (10 times) Coughing vigorously (10 times) (Subject should be standing) Running on the spot (1 min) Bending to pick up an object from the floor (5 times) • The weight of the pad is measured to determine the amount of leakage.	Change in 1 hour Pad Weight Test Values at 5 Months from Baseline

Collaborators and Investigators

• Sponsor: Viveve Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): August 30, 2020
• Study Completion (Actual): August 30, 2020

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 20, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: VI-19-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes