A Study to Measure the Degree and Effectiveness of the Various vSculpt Operating Modes
NCT ID: NCT02856490
Last Updated: 2021-11-24
Study Results
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View full resultsBasic Information
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COMPLETED
6 participants
INTERVENTIONAL
2016-07-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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vSculpt with Vibration Only
vSculpt genital device used in vibration mode only.
vSculpt
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 and Light
vSculpt genital device used in vibration and light mode.
vSculpt
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
InTone genital device using electric muscle stimulation only.
InTone
A genital device using electric muscle stimulation to treat incontinence.
Interventions
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vSculpt
A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles.
InTone
A genital device using electric muscle stimulation to treat incontinence.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
48 Years
60 Years
FEMALE
Yes
Sponsors
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Joylux, Inc.
OTHER
Responsible Party
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Locations
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San Diego Sexual Medicine
San Diego, California, United States
Countries
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Other Identifiers
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JOY 1515-02
Identifier Type: -
Identifier Source: org_study_id