Clinical Evaluation of the Safety and Efficacy of Using Multi-Polar RF and PEMF Technologies for the Treatment of Symptoms Associated With Vulvovaginal Atrophy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Genitourinary Syndrome of Menopause
- Sponsor
- Venus Concept
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Vaginal Health Index
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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. 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Female Sexual Function Index (FSFI)(Six months)