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

Completed

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
vSculpt with Vibration and Light	vSculpt	vSculpt genital device used in vibration and light mode.
vSculpt with Vibration Only	vSculpt	vSculpt genital device used in vibration mode only.
InTone Device	InTone	InTone genital device using electric muscle stimulation only.

Primary Outcome Measures

Name	Time	Method
Change in Blood Flow as Measured by Temperature Change in the Genitalia Using Thermography Technology	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.

Secondary Outcome Measures

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