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

NCT ID: NCT03536585

Last Updated: 2023-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-03
• Study Completion Date: 2022-12-31

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.

Conditions

Vulvovaginal Atrophy; Menopause; Menopause Surgical

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Vulvovaginal treatment

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

Group Type: EXPERIMENTAL

Vulvovaginal treatment

Intervention Type: DEVICE

• Radiofrequency and pulsed electro-magnetic fields treatment of the vaginal canal to maintain an internal temperature of approximately 42 C for the proximal thermometer and 45 C for the mid and distal thermometers for 15 minutes.
• Radiofrequency and pulsed electro-magnetic fields treatment of the labia to maintain an external temperature of approximately 40 C - 45 C for 15 minutes.
• Radiofrequency and pulsed electro-magnetic fields treatment of the mons pubis to maintain an external temperature of approximately 40 C - 47 C for 15 minutes.

Baseline

Intervention Type: DEVICE

Subject is acting as their own control. The baseline general appearance photograph will act as the comparator.

Baseline

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vulvovaginal treatment

• Radiofrequency and pulsed electro-magnetic fields treatment of the vaginal canal to maintain an internal temperature of approximately 42 C for the proximal thermometer and 45 C for the mid and distal thermometers for 15 minutes.
• Radiofrequency and pulsed electro-magnetic fields treatment of the labia to maintain an external temperature of approximately 40 C - 45 C for 15 minutes.
• Radiofrequency and pulsed electro-magnetic fields treatment of the mons pubis to maintain an external temperature of approximately 40 C - 47 C for 15 minutes.

Intervention Type: DEVICE

Baseline

Subject is acting as their own control. The baseline general appearance photograph will act as the comparator.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Venus Concept

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Cardarelli

Role: STUDY_DIRECTOR

Venus Concept

Locations

Southern Health Centre

White Rock, British Columbia, Canada

Dr. George Arnold

Markham, Ontario, Canada

Pearl MD Rejuvenation

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

CS0716

Identifier Type: -

Identifier Source: org_study_id