Vulvovaginal AtrophyNCT03536585
Multi-polar RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
A study testing Vulvovaginal treatment and Baseline in people with Vulvovaginal Atrophy and Menopause, run by Venus Concept at 3 sites in Canada.
Trial summary
The study evaluates the use of multi-polar radiofrequency (RF) and pulsed electro-magnetic fields (PEMF) energies for the treatment of vaginal looseness and for the treatment of the mons pubis and labia for skin tightening. Read more about this study
- Who is it for?
- Ages 30 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvovaginal Atrophy, Menopause, Menopause Surgical
- What is being tested?
- Vulvovaginal treatment and Baseline
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 3 sitesCanada
- Study dates
- 3 May 2018to 31 Dec 2022
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female subjects, ≥30 years of age who are post-menopausal, or women who have undergone surgically induced menopause and are not able to bear children.
- Requesting treatment for vaginal laxity with a score of ˂4 on the VLQ and are requesting treatment of the mons pubis and labia for skin laxity.
- Sexual activity (vaginal intercourse minimum twice per month) in a monogamous relationship.
- Negative Papanicolaou (Pap) Smear Cytology Test within 3 months prior to enrollment.
Who cannot join
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- Having a permanent implant in the treated area.
- Prior use of collagen, fat injections and/or other methods of skin augmentation (enhancement with injected or implanted material) in the treated area within 4-6 weeks of the initial treatment or during the course of the study.
- Use of retinoids such as oral Isotretinoin (Accutane®) within 6 months of initial treatment or during the course of the study.
- Any other surgery in treated area within 12 months of initial treatment or during the course of the study.
- Open laceration, abrasion or bleeding of any sort on the area to be treated.
Show all 18Show fewer
- Active sexual transmitted disease (STD) (e.g. genital Herpes Simplex, condylomata) or vaginosis.
- Chronic vulvar pain or vulvar dystrophy.
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications, including corticosteroids, 6 months prior to and during the course of the study.
- Having any form of active cancer at the time of enrollment and during the course of the study.
- Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Investigator would interfere with the treatment, or healing process.
- Having any stage 3-4 cystocele, rectocele, enterocele paravaginal defect or major pelvic organ prolapse beyond the hymenal ring.
- Skin piercing in the treatment area.
- Tattoos in the treatment area.
- Prior procedure in the treated area with laser or other device within 12 months of the initial treatment or during the course of treatment.
- History of keloid formation or poor wound healing in a previously-injured skin area.
- 21. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
- 21. Use of an intrauterine device during the course of treatment.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Dr. George Arnold
Markham, Ontario, L6B 0T1
Pearl MD Rejuvenation
Toronto, Ontario, M4T 2A2
Southern Health Centre
White Rock, British Columbia, V4B 5C9
About this study
Official title: Clinical Evaluation of the Safety and Efficacy of Using Multi-Polar RF and PEMF Technologies for the Treatment of Vaginal Laxity and for Treatment of the Mons Pubis and Labia for Improvement of Skin Laxity
The study evaluates the use of multi-polar radiofrequency (RF) and pulsed electro-magnetic fields (PEMF) energies for the treatment of vaginal looseness and for the treatment of the mons pubis and labia for skin tightening. All subjects will receive a total of three internal and three external treatments at four week intervals. Subjects will be followed up at one and four months after treatment is complete.
Read the detailed description
Traditional non-surgical treatments to treat vaginal looseness include Kegel exercises or pelvic floor therapy with electrical stimulation of the vaginal muscles to promote muscle strength but may not be all that effective. Surgery is also used to tighten the vaginal canal and reduce the size of the mons pubis and the outer labial lips but can be associated with surgical complications. Development of new technologies to address these concerns is warranted.
Mutil-polar radiofrequency (RF) therapy to treat stress incontinence (attributed to looseness of the muscles that control the ability to hold urine) and looseness of the facial and neck skin has been used with success and minimal risk. The addition of pulsed electromagnetic field (PEMF) energy to multi-polar RF therapy has also been shown to improve the results of the RF therapy.
RF therapy has already been reported to be successful in vaginal tightening. This study will investigate whether adding PEMF to RF therapy is safe and efficacious for the treatment of vaginal loosenss. In addition, this study will also investigate whether RF and PEMF energy treatment will improve the looseness of the mons pubis and labia.
- Conditions
- Vulvovaginal Atrophy, Menopause, Menopause Surgical
- Being tested
- Vulvovaginal treatment, Baseline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vulvovaginal treatmentDevice
- Radiofrequency and pulsed electro-magnetic fields treatment of the vaginal canal to maintain an internal temperature of approximately 42 C for the proximal thermometer and 45 C for the mid and distal thermometers for 15 minutes.
- Radiofrequency and pulsed electro-magnetic fields treatment of the labia to maintain an external temperature of approximately 40 C - 45 C for 15 minutes.
- Radiofrequency and pulsed electro-magnetic fields treatment of the mons pubis to maintain an external temperature of approximately 40 C - 47 C for 15 minutes.
BaselineDevice
Subject is acting as their own control. The baseline general appearance photograph will act as the comparator.
| Study group | Role | What they receive |
|---|---|---|
| Vulvovaginal treatment | Experimental | Internal vaginal treatment monthly for 3 treatments; External mons pubis treatment monthly for 3 treatments; External labia treatment monthly for 3 treatments. Receives: Device: Vulvovaginal treatment; Device: Baseline |
| Baseline | No intervention | Subject's baseline photograph to act as their own control for the one-month and four-month post-treatment photograph of the mons pubis and labia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Laxity
Self reported improvement in vaginal laxity defined as a score > 4 on Vaginal Laxity Questionnaire (VLQ) where 1 = very loose, 2 = moderately loose, 3 = slightly loose, 4 = neither tight nor loose, 5 = slightly tight, 6 = moderately tight and 7 = very tight.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start3 May 2018
- Primary completion31 Mar 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal AtrophyStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venus Concept
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Cardarelli, Study director, Venus Concept
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536585
- Sponsor's protocol ID
- CS0716
- Status last verified
- May 2023
- First submitted
- 14 May 2018
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Safety and Efficacy of Using Multi-Polar RF and PEMF Technologies for the Treatment of Vaginal Laxity and for Treatment of the Mons Pubis and Labia for Improvement of Skin Laxity
- ClinicalTrials.gov ID
- NCT03536585
- Acronym / sponsor ID
- CS0716
- Conditions
- Vulvovaginal Atrophy, Menopause, Menopause Surgical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Venus ConceptIndustry (pharma, biotech, devices)
- Study start
- 3 May 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 24 May 2018 (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.
The study evaluates the use of multi-polar radiofrequency (RF) and pulsed electro-magnetic fields (PEMF) energies for the treatment of vaginal looseness and for the treatment of the mons pubis and labia for skin tightening. All subjects will receive a total of three internal and three external treatments at four week intervals. Subjects will be followed up at one and four months after treatment is complete.
Detailed description
Traditional non-surgical treatments to treat vaginal looseness include Kegel exercises or pelvic floor therapy with electrical stimulation of the vaginal muscles to promote muscle strength but may not be all that effective. Surgery is also used to tighten the vaginal canal and reduce the size of the mons pubis and the outer labial lips but can be associated with surgical complications. Development of new technologies to address these concerns is warranted.
Mutil-polar radiofrequency (RF) therapy to treat stress incontinence (attributed to looseness of the muscles that control the ability to hold urine) and looseness of the facial and neck skin has been used with success and minimal risk. The addition of pulsed electromagnetic field (PEMF) energy to multi-polar RF therapy has also been shown to improve the results of the RF therapy.
RF therapy has already been reported to be successful in vaginal tightening. This study will investigate whether adding PEMF to RF therapy is safe and efficacious for the treatment of vaginal loosenss. In addition, this study will also investigate whether RF and PEMF energy treatment will improve the looseness of the mons pubis and labia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vulvovaginal treatment | Experimental | Device: Vulvovaginal treatment, Device: BaselineInternal vaginal treatment monthly for 3 treatments; External mons pubis treatment monthly for 3 treatments; External labia treatment monthly for 3 treatments. |
| Baseline | No intervention | –Subject's baseline photograph to act as their own control for the one-month and four-month post-treatment photograph of the mons pubis and labia. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy female subjects, ≥30 years of age who are post-menopausal, or women who have undergone surgically induced menopause and are not able to bear children.
- Requesting treatment for vaginal laxity with a score of ˂4 on the VLQ and are requesting treatment of the mons pubis and labia for skin laxity.
- Sexual activity (vaginal intercourse minimum twice per month) in a monogamous relationship.
- Negative Papanicolaou (Pap) Smear Cytology Test within 3 months prior to enrollment.
Key exclusion criteria (18 listed)
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- Having a permanent implant in the treated area.
- Prior use of collagen, fat injections and/or other methods of skin augmentation (enhancement with injected or implanted material) in the treated area within 4-6 weeks of the initial treatment or during the course of the study.
- Use of retinoids such as oral Isotretinoin (Accutane®) within 6 months of initial treatment or during the course of the study.
- Any other surgery in treated area within 12 months of initial treatment or during the course of the 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 |
|---|---|---|
| Vulvovaginal treatment* Radiofrequency and pulsed electro-magnetic fields treatment of the vaginal canal to maintain an internal temperature of approximately 42 C for the proximal thermometer and 45 C for the mid and distal thermometers for 15 minutes. * Radiofrequency and pulsed electro-magnetic fields treatment of the labia to maintain an external temperature of approximately 40 C - 45 C for 15 minutes. * Radiofrequency and pulsed electro-magnetic fields treatment of the mons pubis to maintain an external temperature of approximately 40 C - 47 C for 15 minutes. | Device | Vulvovaginal treatment |
| BaselineSubject is acting as their own control. The baseline general appearance photograph will act as the comparator. | Device | Vulvovaginal treatment |
Primary outcome
Vaginal Laxity
Time frame: Six months
Self reported improvement in vaginal laxity defined as a score > 4 on Vaginal Laxity Questionnaire (VLQ) where 1 = very loose, 2 = moderately loose, 3 = slightly loose, 4 = neither tight nor loose, 5 = slightly tight, 6 = moderately tight and 7 = very tight.
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 2 Jun 2023.
Related trials for Vulvovaginal Atrophy
RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Recruiting
A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Female Urogenital Diseases, Breast Cancer Female
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
RecruitingObservational study
Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors
Genitourinary Syndrome of Menopause (GSM), Breast Cancer
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.
Paul Cardarelli study director
Venus Concept
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vulvovaginal treatment and Baseline in people with Vulvovaginal Atrophy and Menopause, run by Venus Concept at 3 sites in Canada.
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 18 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 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
Vaginal Laxity (time frame: Six months). 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 2 Jun 2023.