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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Sexual Dysfunction, Stress Incontinence

Intervention / Treatment
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* Device: vSculpt
* Device: InTone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 48 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vSculpt with Vibration Only<br>vSculpt genital device used in vibration mode only. | Device: vSculpt<br>* A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles.<br>|
| Active Comparator: vSculpt with Vibration and Light<br>vSculpt genital device used in vibration and light mode. | Device: vSculpt<br>* A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles.<br>|
| Active Comparator: InTone Device<br>InTone genital device using electric muscle stimulation only. | Device: InTone<br>* A genital device using electric muscle stimulation to treat incontinence.<br>* Other names: ApexM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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. | 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. | 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) | 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) | 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 |