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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vulvovaginal treatment | Experimental | Internal vaginal treatment monthly for 3 treatments; External mons pubis treatment monthly for 3 treatments; External labia treatment monthly for 3 treatments. |
|
| Baseline | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vulvovaginal treatment | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal Laxity | 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. | Six months |
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Inclusion Criteria:
Exclusion Criteria:
21. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
21. Use of an intrauterine device during the course of treatment.
Eligible subjects must be post-menopausal or have undergone surgical menopause.
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| Name | Affiliation | Role |
|---|---|---|
| Paul Cardarelli | Venus Concept | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Health Centre | White Rock | British Columbia | V4B 5C9 | Canada | ||
| Dr. George Arnold |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Independent reviewer to identify the one-month and four-month post-treatment photograph of the mons pubis and labia.
|
| Baseline | Device | Subject is acting as their own control. The baseline general appearance photograph will act as the comparator. |
|
| Markham |
| Ontario |
| L6B 0T1 |
| Canada |
| Pearl MD Rejuvenation | Toronto | Ontario | M4T 2A2 | Canada |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |