Clinical trial NCT03536585: Multi-polar RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvovaginal Atrophy
Menopause
Menopause Surgical
Lead sponsor: Venus Concept
Sponsor class: INDUSTRY
First posted: 2018-05-24
Enrollment: 63
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

21. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).

21. Use of an intrauterine device during the course of treatment.

Primary outcomes:
measure: Vaginal Laxity
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: White Rock
country: Canada
facility: Southern Health Centre
state: British Columbia
city: Markham
country: Canada
facility: Dr. George Arnold
state: Ontario
city: Toronto
country: Canada
facility: Pearl MD Rejuvenation
state: Ontario
Study officials:
affiliation: Venus Concept
name: Paul Cardarelli
role: STUDY_DIRECTOR
References: