Pelvic Floor DisordersNCT03073824
A Long-term Evaluation of a Novel Intravaginal Device
A study testing vSculpt in people with Pelvic Floor Disorders and Sexual Dysfunction, run by Joylux, Inc. at 2 sites in United States.
Trial summary
An open-label long-term evaluation of a novel intravaginal device in female patients experiencing sexual and bladder function issues. Read more about this study
- Who is it for?
- Ages 30 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders, Sexual Dysfunction, Stress Incontinence
- What is being tested?
- vSculpt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Mar 2017to 29 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All study participants are required to be biological females (genotype XX) to participate
- Female participants will be of adult age, over 18
- Female participants with self-reported concerns with bladder and sexual function
- Female participants who have reliable and consistent computer and internet access on a daily basis
Who cannot join
- Female participants shall not have an active sexually transmitted disease and/or infection
- Female participants who are actively undergoing chemotherapy or radiation
- Female participants who are currently taking any cancer-related or photosensitivity drugs
- Female participants who are pregnant, who may think they are pregnant, and/or actively trying to get pregnant during the clinical study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Egrari Non Invasive Center
Bellevue, Washington, 98004
Seattle Obstetrics and Gynecology Group
Seattle, Washington, 98104
About this study
Official title: An Open-label Long-term Evaluation of a Novel Intravaginal Device in Female Patients Experiencing Sexual and Bladder Function Issues
An open-label long-term evaluation of a novel intravaginal device in female patients experiencing sexual and bladder function issues.
Read the detailed description
To determine the long-term clinical efficacy of the vSculpt therapy on treating the pelvic floor area and vaginal tissue for females who experience bladder and sexual dysfunction.
- Being tested
- vSculpt
- Medical subject headings
- Pelvic Floor Disorders, 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
Pelvic Floor Toning and Vaginal Rejuvenation Device
| Study group | Role | What they receive |
|---|---|---|
| vSculpt, model #VS1100 | Experimental | A novel intravaginal device for females Receives: Device: vSculpt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Patient Quality of Life as Measured by Female Sexual Response Index
Improvement in patient quality of life as measured by an improvement in Female Sexual Function Index (FSFI) scores.
Measured: 365 days
Improvement in patient quality of life as measured by the Female Sexual Distress
Improvement in patient quality of life as measured by an improvement Female Sexual Distress Score (FSDS) scores.
Measured: 365 days
Improvement in patient quality of life as measured by the Urogenital Distress Inventory, Short Form (UDI-6)
Improvement in patient quality of life as measured by an improvement Urogenital Distress Inventory, Short Form (UDI-6) scores.
Measured: 365 days
Improvement in patient quality of life as measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7)
Improvement in patient quality of life as measured by an improvement Incontinence Impact Questionnaire, Short Form (IIQ-7) scores.
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start6 Mar 2017
- Primary completion29 Nov 2018
- Study completion29 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies 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
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joylux, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah De La Torre, MD, Principal investigator, Seattle OB/GYN Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073824
- Sponsor's protocol ID
- JOY 1515-03
- Status last verified
- Nov 2018
- First submitted
- 24 Feb 2017
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Long-term Evaluation of a Novel Intravaginal Device in Female Patients Experiencing Sexual and Bladder Function Issues
- ClinicalTrials.gov ID
- NCT03073824
- Acronym / sponsor ID
- JOY 1515-03
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Joylux, Inc.University, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 29 Nov 2018 (actual)
- Study completion
- 29 Nov 2018 (actual)
- First posted
- 8 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label long-term evaluation of a novel intravaginal device in female patients experiencing sexual and bladder function issues.
Detailed description
To determine the long-term clinical efficacy of the vSculpt therapy on treating the pelvic floor area and vaginal tissue for females who experience bladder and sexual dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vSculpt, model #VS1100 | Experimental | Device: vSculptA novel intravaginal device for females |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All study participants are required to be biological females (genotype XX) to participate
- Female participants will be of adult age, over 18
- Female participants with self-reported concerns with bladder and sexual function
- Female participants who have reliable and consistent computer and internet access on a daily basis
Key exclusion criteria (4 listed)
- Female participants shall not have an active sexually transmitted disease and/or infection
- Female participants who are actively undergoing chemotherapy or radiation
- Female participants who are currently taking any cancer-related or photosensitivity drugs
- Female participants who are pregnant, who may think they are pregnant, and/or actively trying to get pregnant during the clinical study
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 |
|---|---|---|
| vSculptPelvic Floor Toning and Vaginal Rejuvenation Device | Device | vSculpt, model #VS1100 |
Primary outcome
Improvement in Patient Quality of Life as Measured by Female Sexual Response Index
Time frame: 365 days
Improvement in patient quality of life as measured by an improvement in Female Sexual Function Index (FSFI) scores.
Improvement in patient quality of life as measured by the Female Sexual Distress
Time frame: 365 days
Improvement in patient quality of life as measured by an improvement Female Sexual Distress Score (FSDS) scores.
Improvement in patient quality of life as measured by the Urogenital Distress Inventory, Short Form (UDI-6)
Time frame: 365 days
Improvement in patient quality of life as measured by an improvement Urogenital Distress Inventory, Short Form (UDI-6) scores.
Improvement in patient quality of life as measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7)
Time frame: 365 days
Improvement in patient quality of life as measured by an improvement Incontinence Impact Questionnaire, Short Form (IIQ-7) scores.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Pelvic Floor Disorders
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Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
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Not yet recruitingObservational study
Clinical, Functional, and Therapeutic Characterization of Women With Urinary Incontinence and Analysis of Factors Associated With Treatment Response
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Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
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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.
Sarah De La Torre, MD principal investigator
Seattle OB/GYN Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vSculpt in people with Pelvic Floor Disorders and Sexual Dysfunction, run by Joylux, Inc. at 2 sites 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 4 inclusion and 4 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 3 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in Patient Quality of Life as Measured by Female Sexual Response Index (time frame: 365 days). The study lists 4 primary outcomes in all. 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 3 Dec 2018.