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

Joylux

Status: Completed

Conditions: Sexual Dysfunction; Stress Incontinence

Treatments: Device: InTone; Device: vSculpt

Study type: Interventional

Funder types: Other

Identifiers

NCT02856490

JOY 1515-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 6 patients

Sex: Female

Ages: 48 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 3 patient groups

vSculpt with Vibration Only

Active Comparator group

Description:

vSculpt genital device used in vibration mode only.

Treatment:

Device: vSculpt

vSculpt with Vibration and Light

Active Comparator group

Description:

vSculpt genital device used in vibration and light mode.

Treatment:

Device: vSculpt

InTone Device

Active Comparator group

Description:

InTone genital device using electric muscle stimulation only.

Treatment:

Device: InTone