Multi-polar RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement … (NCT03536585) | Clinical Trial Compass
CompletedNot Applicable
Multi-polar RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
Canada63 participantsStarted 2018-05-03
Plain-language 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.
Who can participate
Age range30 Years – 80 Years
SexFEMALE
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Inclusion criteria
✓. 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.
✓. 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.
✓. Sexual activity (vaginal intercourse minimum twice per month) in a monogamous relationship.
✓. Negative Papanicolaou (Pap) Smear Cytology Test within 3 months prior to enrollment.
Exclusion criteria
✕. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
✕. Having a permanent implant in the treated area.
✕. 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.
✕. Use of retinoids such as oral Isotretinoin (Accutane®) within 6 months of initial treatment or during the course of the study.
✕. Any other surgery in treated area within 12 months of initial treatment or during the course of the study.
✕. Open laceration, abrasion or bleeding of any sort on the area to be treated.
✕. Active sexual transmitted disease (STD) (e.g. genital Herpes Simplex, condylomata) or vaginosis.