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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03536585
Recruitment Status : Active, not recruiting
First Posted : May 24, 2018
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Venus Concept

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.

Condition or disease Intervention/treatment Phase
Vulvovaginal Atrophy Menopause Menopause Surgical Device: Vulvovaginal treatment Device: Baseline Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Independent reviewer to identify the one-month and four-month post-treatment photograph of the mons pubis and labia.
Primary Purpose: Treatment
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
Actual Study Start Date : May 3, 2018
Actual Primary Completion Date : September 5, 2019
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vulvovaginal treatment
Internal vaginal treatment monthly for 3 treatments; External mons pubis treatment monthly for 3 treatments; External labia treatment monthly for 3 treatments.
Device: 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.

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

No Intervention: 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.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Eligible subjects must be post-menopausal or have undergone surgical menopause.
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536585


Locations
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Canada, British Columbia
Southern Health Centre
White Rock, British Columbia, Canada, V4B 5C9
Canada, Ontario
Dr. George Arnold
Markham, Ontario, Canada, L6B 0T1
Pearl MD Rejuvenation
Toronto, Ontario, Canada, M4T 2A2
Sponsors and Collaborators
Venus Concept
Investigators
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Study Director: Paul Cardarelli Venus Concept
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Responsible Party: Venus Concept
ClinicalTrials.gov Identifier: NCT03536585    
Other Study ID Numbers: CS0716
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrophy
Pathological Conditions, Anatomical