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

NCT02856490 · Status: COMPLETED · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-11-24

Study results available
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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

Interventions

DEVICE

vSculpt

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

DEVICE

InTone

A genital device using electric muscle stimulation to treat incontinence.

Sponsors & Collaborators

  • Joylux, Inc.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
48 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02856490 on ClinicalTrials.gov