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

Primary Purpose

Sexual Dysfunction, Stress Incontinence

Status
Completed
Phase
Locations
United States
Study Type
Interventional
Intervention
vSculpt
InTone
Sponsored by
Joylux, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexual Dysfunction

Eligibility Criteria

48 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • San Diego Sexual Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

vSculpt with Vibration Only

vSculpt with Vibration and Light

InTone Device

Arm Description

vSculpt genital device used in vibration mode only.

vSculpt genital device used in vibration and light mode.

InTone genital device using electric muscle stimulation only.

Outcomes

Primary Outcome Measures

Change in Blood Flow as Measured by Temperature Change in the Genitalia Using Thermography Technology
The primary outcomes assessed will be change in blood flow as measured by temperature change in Celsius in the genitalia using thermography technology.

Secondary Outcome Measures

Patient Quality of Life as Measured by Female Sexual Function Index (FSFI) Scores at Baseline and 30 Days Post Treatment.
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.
Patient Quality of Life as Measured by Female Sexual Distress Scores (FSDS) at Baseline and 30 Days Post Treatment.
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.
Patient Quality of Life as Measured by the Urogenital Distress Inventory, Short Form (UDI-6)
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.
Patient Quality of Life as Measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7)
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.

Full Information

First Posted
August 2, 2016
Last Updated
October 29, 2021
Sponsor
Joylux, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02856490
Brief Title
A Study to Measure the Degree and Effectiveness of the Various vSculpt Operating Modes
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joylux, Inc.

4. Oversight

Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Stress Incontinence

7. Study Design

Primary Purpose
Treatment
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vSculpt with Vibration Only
Arm Type
Active Comparator
Arm Description
vSculpt genital device used in vibration mode only.
Arm Title
vSculpt with Vibration and Light
Arm Type
Active Comparator
Arm Description
vSculpt genital device used in vibration and light mode.
Arm Title
InTone Device
Arm Type
Active Comparator
Arm Description
InTone genital device using electric muscle stimulation only.
Intervention Type
Device
Intervention Name(s)
vSculpt
Intervention Description
A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles.
Intervention Type
Device
Intervention Name(s)
InTone
Other Intervention Name(s)
ApexM
Intervention Description
A genital device using electric muscle stimulation to treat incontinence.
Primary Outcome Measure Information:
Title
Change in Blood Flow as Measured by Temperature Change in the Genitalia Using Thermography Technology
Description
The primary outcomes assessed will be change in blood flow as measured by temperature change in Celsius in the genitalia using thermography technology.
Time Frame
Pre and post treatment at baseline and pre and post treatment at day 30
Secondary Outcome Measure Information:
Title
Patient Quality of Life as Measured by Female Sexual Function Index (FSFI) Scores at Baseline and 30 Days Post Treatment.
Description
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.
Time Frame
Baseline and 30 days
Title
Patient Quality of Life as Measured by Female Sexual Distress Scores (FSDS) at Baseline and 30 Days Post Treatment.
Description
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.
Time Frame
Baseline and 30 days
Title
Patient Quality of Life as Measured by the Urogenital Distress Inventory, Short Form (UDI-6)
Description
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.
Time Frame
Baseline and 30 days
Title
Patient Quality of Life as Measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7)
Description
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.
Time Frame
Baseline and 30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
48 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
San Diego Sexual Medicine
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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