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 Details — Status: Completed

Administrative data

• NCT number: NCT02856490
• Other study ID #: JOY 1515-02
• Status: Completed
• Start date: July 2016
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: Joylux, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 48 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Sexual Dysfunction
• Stress Incontinence
• Urinary Incontinence, Stress

Intervention

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.
• InTone
A genital device using electric muscle stimulation to treat incontinence.

Locations

Country	Name	City	State
United States	San Diego Sexual Medicine	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Joylux, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre and post treatment at baseline and pre and post treatment at day 30
Secondary	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.	Baseline and 30 days
Secondary	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.	Baseline and 30 days
Secondary	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.	Baseline and 30 days
Secondary	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.	Baseline and 30 days