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A Study to Measure the Degree and Effectiveness of the Various vSculpt Operating Modes

Sexual Dysfunction Clinical Trial

Official title:
A Pilot Study to Determine the Degree and Effectiveness of the Various Operating Modes of vSculpt on Enhancing Genital Blood Flow and Improving Quality of Life in Women Who Experience Sexual Dysfunction and Stress Incontinence

Clinical Trial Summary

A pilot study to determine the degree and effectiveness of the various modes of vSculpt, an over-the-counter "OTC" medical device, on enhanced genital blood flow and improvement in quality of life in menopausal women who suffer sexual dysfunction and stress incontinence

Clinical Trial Description

The primary aim of this study is to determine the degree and effectiveness of the various modes of vSculpt on enhanced genital blood flow with menopausal women who experience sexual dysfunction and stress incontinence as measured by temperature change in the genitalia immediately after initial and final treatment and an improvement in quality of life after using the vSculpt device over the course of four weeks. The secondary aim is to compare the differences in genital blood flow and improvement in quality of life of vSculpt's various modes against Intone, another over-the-counter "OTC" medical device that utilizes a different technology to treat stress incontinence and improve sexual dysfunction. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02856490
Study type Interventional
Source Joylux, Inc.
Contact
Status Completed
Phase
Start date July 2016
Completion date December 2016
View Details
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