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

Venus Concept

Status: Completed

Conditions: Menopause Surgical; Menopause; Vulvovaginal Atrophy

Treatments: Device: Baseline; Device: Vulvovaginal treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT03536585

CS0716

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: Female

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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63 participants in 2 patient groups

Vulvovaginal treatment

Experimental group

Description:

Internal vaginal treatment monthly for 3 treatments; External mons pubis treatment monthly for 3 treatments; External labia treatment monthly for 3 treatments.

Treatment:

Device: Baseline

Device: Vulvovaginal treatment

Baseline

No Intervention group

Description:

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.