NCT02856490

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

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

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Joylux, Inc. · Academic / Other
• Sex: Female
• Age: 48 Years – 60 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Sexual Dysfunction
• Stress Incontinence

Interventions

Type	Name	Description
DEVICE	vSculpt	A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles.
DEVICE	InTone	A genital device using electric muscle stimulation to treat incontinence.

Timeline

• Start date: 2016-07-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-08-05
• Last updated: 2021-11-24
• Results posted: 2021-10-26

Locations

1 site across 1 country: United States