Multi-polar RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Vulvovaginal Atrophy, Menopause, Menopause Surgical

Intervention / Treatment
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* Device: Vulvovaginal treatment
* Device: Baseline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vulvovaginal treatment<br>Internal vaginal treatment monthly for 3 treatments; External mons pubis treatment monthly for 3 treatments; External labia treatment monthly for 3 treatments. | Device: Vulvovaginal treatment<br>* 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.<br>Device: Baseline<br>* Subject is acting as their own control. The baseline general appearance photograph will act as the comparator.<br>|
| No Intervention: Baseline<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Six months |