Abstract
Non-invasive vaginal rejuvenation with radiofrequency (RF) and lasers devices have gained popularity, but well-designed studies confirming their effectiveness are lacking. The aim of this study was to compare the efficacy and safety of a multipolar RF and pulsed electromagnetic field-based device (PEMF) versus sham for vaginal laxity. Thirty-two premenopausal females with ≥ 1 vaginal delivery and self-reported vaginal laxity were randomized into 2 groups: active (RF + PEMF) and sham. Both groups received 3 vaginal treatments at 3-week interval. The Vaginal Laxity Questionnaire (VLQ), perineometer measurements, and Brink score were conducted at baseline, 4, and 12 weeks after treatments. Pre and post-treatment vaginal histology, Female Sexual Function Index (FSFI), subjects’ satisfaction, pain, and adverse events were assessed. The active group VLQ scores increased and were significantly better than the sham group (p < 0.001). At the final follow-up, 50% of the active group reported no vaginal laxity (VLQ > 4) versus 12% in the sham group (p = 0.054). In the active group, all domains of perineometer measurements and Brink scores (p < 0.001), FSFI scores (p < 0.05), and patients’ satisfaction (p < 0.001) were significantly increased and higher in the active group. Mild adverse effects including pain and burning sensation were not different between groups except for itch which was significantly higher in the sham arm (p = 0.014). Histology after RF + PEMF treatments demonstrated neocollagenesis, neoelastogenesis, and neoangiogenesis. In conclusion, combination RF + PEMF therapy was safe, improved vaginal laxity, strengthened pelvic floor muscles, and improved female sexual function for at least 12-week post-procedures with confirmed histological improvements. This study was registered on the Thai Clinical Trials Registry, TCTR20200803002 on 2020–07-30 “retrospectively registered.”
Highlights
Vaginal introital laxity is a common consequences of pregnancy, vaginal childbirth, and connective tissue changing due to aging [1, 2]
Vaginal laxity (VL) may result in loss of physical and sexual sensation during intercourse leading to a negative impact on female sexual function, self-image, and quality of life [5,6,7,8]
Inclusion criteria consisted of females aged 20–45 years old with at least 1 vaginal delivery and self-assessment of vaginal laxity by a Vaginal Laxity Questionnaire (VLQ) score no higher than 3 on the [12, 23, 24]
Summary
Vaginal introital laxity is a common consequences of pregnancy, vaginal childbirth, and connective tissue changing due to aging [1, 2]. The use of non-invasive, energy-based devices including radiofrequency (RF) and lasers as a nonsurgical option for treatment of vaginal laxity (VL), vulvovaginal atrophy (VVA) or genitourinary syndrome of menopause (GSM), orgasmic dysfunction, and stress urinary incontinence (SUI) has recently gained popularity. Both laser and RF treatments induce neocollagenesis, neoelastogenesis, and neovascularization in the submucosa which may contribute to improved tightness of the vaginal canal and may improve sensitivity of vulvovaginal tissues. The mechanism is believed to be secondary to activation of heat shock proteins and triggering of the inflammatory and proliferative cascade [13,14,15,16]
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