Last updated on September 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Vulvovaginal Atrophy | Menopause Surgical | Menopause
  • Age: Between 30 - 80 Years
  • Gender: Female

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Sexual activity (vaginal intercourse minimum twice per month) in a monogamous relationship.
  4. Negative Papanicolaou (Pap) Smear Cytology Test within 3 months prior to enrollment.

Exclusion Criteria:

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

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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