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NCT Number: NCT02856490

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

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

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Key information

Conditions

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

Age range

48 year–60 year

Sex eligibility

Female

Study type

Interventional

Primary location

San Diego Sexual Medicine

San Diego, California, 92120, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

InTone

Device

A genital device using electric muscle stimulation to treat incontinence.

Other names: ApexM

Primary outcomes

  1. Change in Blood Flow as Measured by Temperature Change in the Genitalia Using Thermography Technology

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Joylux, Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 5, 2016
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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