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

Viveve

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Device: Viveve - Sham; Device: Viveve - Active; Device: Viveve - Cryogen-Alone

Study type: Interventional

Funder types: Industry

Identifiers

NCT04206085

VI-19-01

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 3 patient groups

Active treatment

Experimental group

Description:

Radiofrequency and Cryogen

Treatment:

Device: Viveve - Active

Cryogen-Only

Active Comparator group

Description:

Crygen-Only

Treatment:

Device: Viveve - Cryogen-Alone

Sham

Sham Comparator group

Description:

Sham comparator

Treatment:

Device: Viveve - Sham