Multi-polar RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
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|ClinicalTrials.gov Identifier: NCT03536585|
Recruitment Status : Active, not recruiting
First Posted : May 24, 2018
Last Update Posted : September 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Vulvovaginal Atrophy Menopause Menopause Surgical||Device: Vulvovaginal treatment Device: Baseline||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|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.|
|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|
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
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.
- 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.
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
|Canada, British Columbia|
|Southern Health Centre|
|White Rock, British Columbia, Canada, V4B 5C9|
|Dr. George Arnold|
|Markham, Ontario, Canada, L6B 0T1|
|Pearl MD Rejuvenation|
|Toronto, Ontario, Canada, M4T 2A2|
|Study Director:||Paul Cardarelli||Venus Concept|