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

October 29, 2021 updated by: Joylux, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92120
        • San Diego Sexual Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Study participants will be female
  • Female participants who are capable of giving informed consent
  • Female participants who are menopausal who have not had a menses within one year, and are within the ages of 48 and 60
  • Female participants who have had one or more vaginal births
  • Female participants who are currently engaged in vaginal sexual intercourse with a partner
  • Female participants who are presently experiencing bladder control issues either leakage, frequency or urgency
  • Female participants who are presently experiencing pain during sexual intercourse

Exclusion Criteria:

  • Female participants shall not have an active sexually transmitted disease and/or infection
  • Female participants who are actively undergoing chemotherapy
  • Female participants who are currently taking any cancer-related drugs
  • Female participants who are breastfeeding or lactating
  • Female participants who have a medical history of neurological disorders (e.g., multiple sclerosis, Parkinson's disease)
  • Female participants with an active urinary tract infection (UTI)
  • Female participants with active bladder stones
  • Female participants with active bladder tumor(s)
  • Females with prior laser or vaginal rejuvenation surgeries or treatments
  • Females with a medical history of vaginal cancer or radiation or surgery with exception of related to childbirth
  • Females with prior non-invasive treatments (estrogen cream) or pelvic floor physical therapy for the vaginal area/ pelvic floor in the past six month
  • Females with a physical disability precluding her from holding a lithotomy for an hour
  • Females who are homeless

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: vSculpt with Vibration Only
vSculpt genital device used in vibration mode only.
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.
Active Comparator: vSculpt with Vibration and Light
vSculpt genital device used in vibration and light mode.
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.
Active Comparator: InTone Device
InTone genital device using electric muscle stimulation only.
Device: InTone
A genital device using electric muscle stimulation to treat incontinence.
Other Names:
  • ApexM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Blood Flow as Measured by Temperature Change in the Genitalia Using Thermography Technology
Time Frame: Pre and post treatment at baseline and pre and post treatment at day 30
The primary outcomes assessed will be change in blood flow as measured by temperature change in Celsius in the genitalia using thermography technology.
Pre and post treatment at baseline and pre and post treatment at day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Quality of Life as Measured by Female Sexual Function Index (FSFI) Scores at Baseline and 30 Days Post Treatment.
Time Frame: Baseline and 30 days
Change in patient quality of life as measured by an improvement in Female Sexual Function Index (FSFI) scores at baseline and 30 days post treatment. The range being from 2 (minimum) to 36 (maximum), with maximum being better.
Baseline and 30 days
Patient Quality of Life as Measured by Female Sexual Distress Scores (FSDS) at Baseline and 30 Days Post Treatment.
Time Frame: Baseline and 30 days
Change in patient quality of life as measured by an improvement in Female Sexual Distress Scores (FSDS) at baseline and 30 days post treatment. The range being from 0 (minimum) to 52 (maximum), with minimum being better.
Baseline and 30 days
Patient Quality of Life as Measured by the Urogenital Distress Inventory, Short Form (UDI-6)
Time Frame: Baseline and 30 days
Change in patient quality of life as measured by an improvement in Urogenital Distress Inventory, Short Form (UDI-6) scores. The range being from 0 (minimum) to 100 (maximum), with minimum being better.
Baseline and 30 days
Patient Quality of Life as Measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7)
Time Frame: Baseline and 30 days
Change in patient quality of life as measured by an improvement in Incontinence Impact Questionnaire, Short Form (IIQ-7) scores. The range being from 0 (minimum) to 100 (maximum), with minimum being better.
Baseline and 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joylux, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 5, 2016

Study Record Updates

Last Update Posted (Actual)

November 24, 2021

Last Update Submitted That Met QC Criteria

October 29, 2021

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JOY 1515-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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