Ramathibodi Laser Center, Division of Dermatology, Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.
Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.
Lasers Med Sci. 2022 Apr;37(3):1829-1842. doi: 10.1007/s10103-021-03438-3. Epub 2021 Oct 14.
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."
射频（RF）和激光设备的非侵入性阴道年轻化治疗已经广受欢迎，但缺乏设计良好的研究来证实其疗效。本研究旨在比较多极 RF 和脉冲电磁场（PEMF）为基础的设备与假对照治疗阴道松弛的疗效和安全性。32 名有≥1 次阴道分娩且自述阴道松弛的绝经前女性被随机分为 2 组：治疗组（RF+PEMF）和假对照组。两组均在 3 周间隔内接受 3 次阴道治疗。在治疗前、治疗后 4 周和 12 周时分别进行阴道松弛问卷（VLQ）、会阴测压计测量和 Brink 评分。评估治疗前后的阴道组织学、女性性功能指数（FSFI）、患者满意度、疼痛和不良反应。治疗组的 VLQ 评分增加，明显优于假对照组（p<0.001）。在最终随访时，治疗组有 50%的患者报告无阴道松弛（VLQ>4），而假对照组为 12%（p=0.054）。在治疗组中，所有会阴测压计测量和 Brink 评分的领域（p<0.001）、FSFI 评分（p<0.05）和患者满意度（p<0.001）均显著增加，且治疗组更高。除瘙痒外（p=0.014），两组间的轻度不良反应（包括疼痛和烧灼感）无差异。RF+PEMF 治疗后的组织学显示新的胶原形成、新的弹性形成和新的血管生成。总之，组合 RF+PEMF 治疗安全、改善阴道松弛、增强盆底肌肉功能，并改善女性性功能，至少在治疗后 12 周时得到确认，且组织学得到改善。本研究于 2020 年 7 月 30 日在泰国临床试验注册中心注册，注册号为 TCTR20200803002（“回溯注册”）。
