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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04206085
• Other study ID #: VI-19-01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: August 30, 2020

Study information

• Verified date: May 2020
• Source: Viveve Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Viveve - Active
Radiofrequency and Cryogen-Cooling
• Viveve - Cryogen-Alone
Cryogen-Cooling
• Viveve - Sham
Sham

Locations

Country	Name	City	State
Canada	Milestone Research	London	Ontario
Canada	Bluewater Clinical Research Group	Sarnia	Ontario
Canada	Devonshire Clinical Research	Woodstock	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Viveve Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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