Sexual DysfunctionNCT02856490
A Study to Measure the Degree and Effectiveness of the Various vSculpt Operating Modes
A study testing vSculpt and InTone in people with Sexual Dysfunction and Stress Incontinence, run by Joylux, Inc. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 48 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Dysfunction, Stress Incontinence
- What is being tested?
- vSculpt and InTone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
San Diego Sexual Medicine
San Diego, California, 92120
About this study
Official 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
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
Read the detailed 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.
- Conditions
- Sexual Dysfunction, Stress Incontinence
- Being tested
- vSculpt, InTone
- Medical subject headings
- Sexual Dysfunction, Physiological, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vSculptDevice
A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles.
InToneDevice
Also called ApexM
A genital device using electric muscle stimulation to treat incontinence.
| Study group | Role | What they receive |
|---|---|---|
| vSculpt with Vibration Only | Active comparator | vSculpt genital device used in vibration mode only. Receives: Device: vSculpt |
| vSculpt with Vibration and Light | Active comparator | vSculpt genital device used in vibration and light mode. Receives: Device: vSculpt |
| InTone Device | Active comparator | InTone genital device using electric muscle stimulation only. Receives: Device: InTone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Baseline and 30 days
Patient Quality of Life as Measured by Female Sexual Distress Scores (FSDS) at Baseline and 30 Days Post Treatment.
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.
Measured: Baseline and 30 days
Patient Quality of Life as Measured by the Urogenital Distress Inventory, Short Form (UDI-6)
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.
Measured: Baseline and 30 days
Patient Quality of Life as Measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7)
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.
Measured: Baseline and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joylux, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856490
- Sponsor's protocol ID
- JOY 1515-02
- Status last verified
- Aug 2016
- First submitted
- 2 Aug 2016
- Last updated
- 24 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02856490
- Acronym / sponsor ID
- JOY 1515-02
- Conditions
- Sexual Dysfunction, Stress Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Joylux, Inc.University, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Posted 26 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vSculpt with Vibration Only | Active comparator | Device: vSculptvSculpt genital device used in vibration mode only. |
| vSculpt with Vibration and Light | Active comparator | Device: vSculptvSculpt genital device used in vibration and light mode. |
| InTone Device | Active comparator | Device: InToneInTone genital device using electric muscle stimulation only. |
Who may qualify
- Ages
- 48 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vSculptA genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles. | Device | vSculpt with Vibration Only, vSculpt with Vibration and Light |
| InToneAlso: ApexMA genital device using electric muscle stimulation to treat incontinence. | Device | InTone Device |
Primary outcome
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.
4 secondary outcomes
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
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
Patient Quality of Life as Measured by the Urogenital Distress Inventory, Short Form (UDI-6)
Time frame: Baseline and 30 days
Patient Quality of Life as Measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7)
Time frame: Baseline and 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vSculpt and InTone in people with Sexual Dysfunction and Stress Incontinence, run by Joylux, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.