Multi-polar RF and PEMF for Treatment of Symptoms Associated With Vulvovaginal Atrophy

This is an interventional treatment trial for Vulvovaginal Atrophy Read More

Inclusion Criteria:

1. Healthy, female subjects, ≥ 19 years of age, requesting treatment of vulvovaginal tissue for improvement of symptoms associated with vulvovaginal atrophy
2. Baseline FSFI score <27.
3. At least one full-term vaginal delivery (of more than 36 weeks gestation) completed at least one year before study enrollment.
4. Able to read, understand and voluntarily provide written Informed Consent.
5. Able and willing to comply with the treatment/follow-up schedule and requirements.
6. Sexually active in a monogamous relationship.
7. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study, and have a negative Urine Pregnancy test at baseline.
8. Negative Papanicolaou (Pap) Smear Cytology Test within 3 months prior to enrollment.

Exclusion Criteria:

1. Pregnant or intending to become pregnant during the course of study.
2. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
3. Having a permanent implant in the treated area (e.g. intrauterine device).
4. 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.
5. Use of retinoids such as oral Isotretinoin (Accutane®) within 6 months of initial treatment or during the course of the study.
6. Any other surgery in treated area within 12 months of initial treatment or during the course of the study.
7. Open laceration, abrasion or bleeding of any sort on the area to be treated.
8. Active sexual transmitted disease (STD) (e.g. genital Herpes Simplex, condylomata) or vaginosis.
9. Chronic vulvar pain or vulvar dystrophy.
10. 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.
11. Having any form of active cancer at the time of enrollment and during the course of the study.
12. 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.
13. 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.
14. Mentally incompetent or evidence of active substance or alcohol abuse.
15. Having any stage 3-4 cystocele, rectocele, enterocele paravaginal defect or major pelvic organ prolapse beyond the hymenal ring.
16. Unstable dosages of medications such as antihypertensives or psychotropics that are known to affect sexuality.
17. Skin piercing in the treatment area.
18. Tattoos in the treatment area.
19. Prior skin treatment with laser in the treated area within 6 months of the initial treatment or during the course of treatment.
20. 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.
21. History of keloid formation or poor wound healing in a previously-injured skin area.
22. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).