Genitourinary Syndrome of MenopauseNCT04607798
Multi-polar RF and PEMF for Treatment of Vulvovaginal Atrophy
A study testing Radiofrequency and pulsed electro-magnetic fields treatment in people with Genitourinary Syndrome of Menopause and Vulvovaginal Atrophy, run by Venus Concept at 1 site in Ukraine.
Trial summary
The study evaluates the use of multi-polar radiofrequency (RF) and pulsed electro-magnetic fields (PEMF) energies for the treatment of symptoms related to genitourinary syndrome of menopause (GSM)/vulvovaginal atrophy (VVA). All subjects will receive a total of three internal treatments at four week intervals. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Genitourinary Syndrome of Menopause, Vulvovaginal Atrophy, Menopause
- What is being tested?
- Radiofrequency and pulsed electro-magnetic fields treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUkraine
- Study dates
- 3 Oct 2017to 31 May 2020
- 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female subjects, ≥19 years of age presenting with symptoms associated with GSM/VVA.
- Requesting treatment for vulvovaginal tissue for improvement of symptoms associated with GSM/VVA, with a score of ˂26.55 on the FSFI.
- Sexual activity (vaginal intercourse minimum twice per month) in a monogamous relationship.
- At least one full-term pregnancy (>36 weeks gestation) with vaginal delivery completed at least one year before study enrollment.
Who cannot join
- Pregnant or intending to become pregnant during the course of study.
- 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 (e.g. intrauterine device)
- 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.
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- Open laceration, abrasion, bleeding, infection or inflammation of any sort on or in the area to be treated.
- 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.
- Participation in a study of another device or drug within 1 month prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria.
- Mentally incompetent or evidence of active substance or alcohol abuse.
- Having any stage 3-4 cystocele, rectocele, enterocele paravaginal defect or major pelvic organ prolapse beyond the hymenal ring.
- Unstable dosages of medications such as antihypertensives or psychotropics that are known to affect sexuality.
- Skin piercing in the treatment area.
- Tattoos in the treatment area.
- Prior skin treatment with laser in the treated area within 6 months of the initial treatment or during the course of treatment.
- Prior ablative resurfacing procedure in the treated area with laser or other devices 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.
- History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
- Menstruation less than 7 days prior to treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Safety and Efficacy of Using Multi-Polar RF and PEMF Technologies for the Treatment of Symptoms Associated With Vulvovaginal Atrophy
The study evaluates the use of multi-polar radiofrequency (RF) and pulsed electro-magnetic fields (PEMF) energies for the treatment of symptoms related to genitourinary syndrome of menopause (GSM)/vulvovaginal atrophy (VVA). All subjects will receive a total of three internal treatments at four week intervals. Subjects will be followed up at one and four months after treatment is complete.
Read the detailed description
Largely observed in the post-menopausal population, a significant subset of pre-menopausal and peri-menopausal women are also affected by symptoms associated with GSM, the etiology being similar in that there is an interruption in normal estrogen production resulting in a hypoestrogenic state. Symptoms related to GSM include vaginal dryness, decreased lubrication, decreased vaginal elasticity, irritation and discomfort of the vaginal and vulvar tissues in general that can affect sexual health. Traditional treatments, such as hormone replacement therapy (HRT), are often the treatment of choice however come with potential risks and many women are not suitable candidates, or have contraindications to its use. Development of new technologies to address these concerns is warranted.
RF energy-based treatment for symptoms of GSM has been used with success to promote elasticity restoration and improve moisture of the vaginal mucosa, and is well established in literature for the treatment of facial and neck laxity, stress urinary incontinence and skin tightening of tissue. Several studies show favorable results with improvement of vaginal laxity and sexual function with RF treatment. The addition of pulsed electromagnetic field (PEMF) energy to multi-polar RF therapy has also been shown to enhance the results of the RF therapy.
RF therapy has already been reported to be successful in treatment of symptoms related to elasticity restoration and improve moisture of the vaginal mucosa. This study will investigate whether adding PEMF to RF therapy is safe and efficacious for the treatment of symptoms related to GSM and sexual health.
- Being tested
- Radiofrequency and pulsed electro-magnetic fields treatment
- Keywords
- Genitourinary Syndrome of Menopause, Menopause, Multi-polar Radio Frequency, Pulsed Electromagnetic Field, Sexual Dysfunction, Vaginal Laxity
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency and pulsed electro-magnetic fields 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.
| Study group | Role | What they receive |
|---|---|---|
| Vulvovaginal treatment | Experimental | Internal vaginal treatment monthly for 3 treatments. Receives: Device: Radiofrequency and pulsed electro-magnetic fields treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Health Index
Clinician assessed improvement in five vaginal parameters; (1) vaginal fluid volume, (2) moisture, (3) vaginal epithelial integrity, (4) elasticity and (5) vaginal pH.
Assessed by the clinician at each visit with baseline comparison made at the one-month and four-month post-treatment assessments.
Measured: Six months
pH
Clinician assessed improvement (reduction) in vaginal pH with baseline comparison made at the one-month and four-month post-treatment assessments.
Measured: Six months
Secondary outcomes (1)
Female Sexual Function Index (FSFI)
Sexual dysfunction criteria (FSFI score ≤26.55) improvement as defined as increased FSFI > 26.55 with treatment; baseline comparison made at the one-month and four-month post-treatment assessments.
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 posted29 Oct 2020
- Study start3 Oct 2017
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Genitourinary Syndrome of MenopauseStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venus Concept
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Gronski, PhD, Study director, Venus Concept
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607798
- Sponsor's protocol ID
- CS0416K
- Status last verified
- Oct 2020
- First submitted
- 22 Oct 2020
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kolodchenko Y. Nonablative, Noncoagulative Multipolar Radiofrequency and Pulsed Electromagnetic Field Treatment Improves Vaginal Laxity and Sexual Function. Womens Health Rep (New Rochelle). 2021 Jul 27;2(1):285-294. doi: 10.1089/whr.2021.0020. eCollection 2021.
PubMed 34327510
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. 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 Symptoms Associated With Vulvovaginal Atrophy
- ClinicalTrials.gov ID
- NCT04607798
- Acronym / sponsor ID
- CS0416K
- Keywords
- Genitourinary Syndrome of Menopause, Menopause, Multi-polar Radio Frequency, Pulsed Electromagnetic Field, Sexual Dysfunction, Vaginal Laxity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Venus ConceptIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 29 Oct 2020 (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 symptoms related to genitourinary syndrome of menopause (GSM)/vulvovaginal atrophy (VVA). All subjects will receive a total of three internal treatments at four week intervals. Subjects will be followed up at one and four months after treatment is complete.
Detailed description
Largely observed in the post-menopausal population, a significant subset of pre-menopausal and peri-menopausal women are also affected by symptoms associated with GSM, the etiology being similar in that there is an interruption in normal estrogen production resulting in a hypoestrogenic state. Symptoms related to GSM include vaginal dryness, decreased lubrication, decreased vaginal elasticity, irritation and discomfort of the vaginal and vulvar tissues in general that can affect sexual health. Traditional treatments, such as hormone replacement therapy (HRT), are often the treatment of choice however come with potential risks and many women are not suitable candidates, or have contraindications to its use. Development of new technologies to address these concerns is warranted.
RF energy-based treatment for symptoms of GSM has been used with success to promote elasticity restoration and improve moisture of the vaginal mucosa, and is well established in literature for the treatment of facial and neck laxity, stress urinary incontinence and skin tightening of tissue. Several studies show favorable results with improvement of vaginal laxity and sexual function with RF treatment. The addition of pulsed electromagnetic field (PEMF) energy to multi-polar RF therapy has also been shown to enhance the results of the RF therapy.
RF therapy has already been reported to be successful in treatment of symptoms related to elasticity restoration and improve moisture of the vaginal mucosa. This study will investigate whether adding PEMF to RF therapy is safe and efficacious for the treatment of symptoms related to GSM and sexual health.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vulvovaginal treatment | Experimental | Device: Radiofrequency and pulsed electro-magnetic fields treatmentInternal vaginal treatment monthly for 3 treatments. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy female subjects, ≥19 years of age presenting with symptoms associated with GSM/VVA.
- Requesting treatment for vulvovaginal tissue for improvement of symptoms associated with GSM/VVA, with a score of ˂26.55 on the FSFI.
- Sexual activity (vaginal intercourse minimum twice per month) in a monogamous relationship.
- At least one full-term pregnancy (>36 weeks gestation) with vaginal delivery completed at least one year before study enrollment.
Key exclusion criteria (23 listed)
- Pregnant or intending to become pregnant during the course of study.
- 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 (e.g. intrauterine device)
- 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.
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 |
|---|---|---|
| Radiofrequency and pulsed electro-magnetic fields treatmentRadiofrequency 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. | Device | Vulvovaginal treatment |
Primary outcome
Vaginal Health Index
Time frame: Six months
Clinician assessed improvement in five vaginal parameters; (1) vaginal fluid volume, (2) moisture, (3) vaginal epithelial integrity, (4) elasticity and (5) vaginal pH. Assessed by the clinician at each visit with baseline comparison made at the one-month and four-month post-treatment assessments.
pH
Time frame: Six months
Clinician assessed improvement (reduction) in vaginal pH with baseline comparison made at the one-month and four-month post-treatment assessments.
1 secondary outcome
Female Sexual Function Index (FSFI)
Time frame: Six months
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 29 Oct 2020.
- Derived from this study: PubMed 34327510Kolodchenko Y. Nonablative, Noncoagulative Multipolar Radiofrequency and Pulsed Electromagnetic Field Treatment Improves Vaginal Laxity and Sexual Function. Womens Health Rep (New Rochelle). 2021 Jul 27;2(1):285-294. doi: 10.1089/whr.2021.0020. eCollection 2021.
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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.
Matthew Gronski, PhD study director
Venus Concept
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency and pulsed electro-magnetic fields treatment in people with Genitourinary Syndrome of Menopause and Vulvovaginal Atrophy, run by Venus Concept at 1 site in Ukraine.
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 23 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 29 Oct 2020. 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 Ukraine. 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 Health Index (time frame: Six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04607798, which also lists 1 linked publication.
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 29 Oct 2020.