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

NCT04206085 | Completed Results FDA Device

• 1 other identifier: VI-19-01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Active treatment

EXPERIMENTAL

Radiofrequency and Cryogen

Device: Viveve - Active

Cryogen-Only

ACTIVE COMPARATOR

Crygen-Only

Device: Viveve - Cryogen-Alone

Sham

SHAM COMPARATOR

Sham comparator

Device: Viveve - Sham

Interventions

Viveve - Active DEVICE

Radiofrequency and Cryogen-Cooling

Active treatment

Viveve - Cryogen-Alone DEVICE

Cryogen-Cooling

Cryogen-Only

Viveve - Sham DEVICE

Sham

Sham

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• hr pad weight at Baseline with a 5 to 50 g net increase from the pre-test pad weight

You may not qualify if:

• 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).

Sponsors & Collaborators

• Viveve Inc.: lead

Study Sites (3)

Milestone Research

London, Ontario, Canada

Location

Bluewater Clinical Research Group

Sarnia, Ontario, Canada

Location

Devonshire Clinical Research

Woodstock, Ontario, Canada

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Vice President, Clinical & Medical Affairs
• Organization: Viveve

clinicalaffairs@viveve.com

720-696-8100

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 20, 2019
• Study Start: January 1, 2020
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: September 21, 2022
• Results First Posted: September 21, 2022

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)