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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vulvovaginal Atrophy
- Sponsor
- Venus Concept
- Enrollment
- 63
- Locations
- 3
- Primary Endpoint
- Vaginal Laxity
- Status
- Completed
- Last Updated
- 2 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 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
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Vaginal Laxity
Time Frame: Six months
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.