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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Viveve - Active
* Device: Viveve - Cryogen-Alone
* Device: Viveve - Sham


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active treatment<br>Radiofrequency and Cryogen | Device: Viveve - Active<br>* Radiofrequency and Cryogen-Cooling<br>|
| Active Comparator: Cryogen-Only<br>Crygen-Only | Device: Viveve - Cryogen-Alone<br>* Cryogen-Cooling<br>|
| Sham Comparator: Sham<br>Sham comparator | Device: Viveve - Sham<br>* Sham<br>|

What is the study measuring?
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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 |