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

NCT02856490 | Completed Results

• 1 other identifier: JOY 1515-02
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

Sexual Dysfunction; Stress Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patient Quality of Life as Measured by Female Sexual Function Index (FSFI) Scores at Baseline and 30 Days Post Treatment.

  Baseline and 30 days

• Patient Quality of Life as Measured by Female Sexual Distress Scores (FSDS) at Baseline and 30 Days Post Treatment.

  Baseline and 30 days

• Patient Quality of Life as Measured by the Urogenital Distress Inventory, Short Form (UDI-6)

  Baseline and 30 days

• Patient Quality of Life as Measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7)

  Baseline and 30 days

Study Arms (3)

vSculpt with Vibration Only

ACTIVE COMPARATOR

vSculpt genital device used in vibration mode only.

Device: vSculpt

vSculpt with Vibration and Light

ACTIVE COMPARATOR

vSculpt genital device used in vibration and light mode.

Device: vSculpt

InTone Device

ACTIVE COMPARATOR

InTone genital device using electric muscle stimulation only.

Device: InTone

Interventions

vSculpt DEVICE

A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles.

vSculpt with Vibration Only; vSculpt with Vibration and Light

InTone DEVICE

A genital device using electric muscle stimulation to treat incontinence.

Also known as: ApexM

InTone Device

Eligibility Criteria

• Age: 48 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joylux, Inc.: lead

Study Sites (1)

San Diego Sexual Medicine

San Diego, California, 92120, United States

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Colette Courtion
• Organization: Joylux

sophia@joylux.com

206.219.6444

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 5, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 24, 2021
• Results First Posted: October 26, 2021

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)