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.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Milestone Research, London, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Viveve - Active

Device

Radiofrequency and Cryogen-Cooling

Viveve - Cryogen-Alone

Device

Cryogen-Cooling

Viveve - Sham

Device

Sham

Primary outcomes

1-hour Pad Weight Test

Time frame: Change in 1 hour Pad Weight Test Values at 5 Months from Baseline
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.

Sponsors and collaborators

Lead sponsor

Viveve Inc.

Industry

Registry information

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Dec 20, 2019
Registry last updated: Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed