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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02856490
Other study ID # JOY 1515-02
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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