Nonablative, Noncoagulative Multipolar Radiofrequency and Pulsed Electromagnetic Field Treatment Improves Vaginal Laxity and Sexual Function

Abstract

Objective: This study investigated nonablative/noncoagulative multipolar radiofrequency and pulsed electromagnetic field (RF/PEMF) treatment for vaginal laxity (VL) and its impact on sexual function in parous women. Methods: This prospective, open-label single-center study enrolled 34 female subjects, 23-59 years of age, with ≥1 vaginal delivery and self-reported VL. Three monthly intravaginal treatments with RF/PEMF energy were performed. Treatment and follow-up assessments included the vaginal health index (VHI), vaginal pH, female sexual function index (FSFI), and VL/sexual satisfaction (SS) and subject satisfaction scores. Mean score and percent improvement over baseline were reported. Subject discomfort/pain was assessed after each treatment. Results: Total and each individual domain scores of the VHI improved significantly, while vaginal pH levels decreased from baseline to both 1 and 4 months (p < 0.01) after the last treatment. FSFI (<0.001), VL (<0.001), and SS (<0.001), including overall satisfaction scores (<0.01), improved post-treatment, with positive effects further sustained until at least 4 months post-treatment. Pain/discomfort post-treatment was reported as none to mild. No noticeable adverse events (AEs) or unanticipated side effects were reported. Conclusions: Nonablative/noncoagulative multipolar RF/PEMF is safe and is associated with significant 1- and 4-month post-treatment improvements in symptoms associated with VL and sexual dysfunction, as assessed by the VHI, vaginal pH, FSFI, and VL subject satisfaction score. SS and overall satisfaction scores also improved. The treatment was well tolerated with no or little pain, and no adverse events were reported. Clinical Trial Registration number: NCT04607798.

Keywords: female sexual dysfunction; multi-polar radio frequency; pulsed electromagnetic field; vaginal laxity.

Conflict of interest statement

Y.K. received funding for the study.

© Yegor Kolodchenko 2021; Published by Mary Ann Liebert, Inc.

Figures

FIG. 1.

Mean VHI per parameter score: baseline, 1 month (FU1), and 4 months (FU2) after the last treatment (n = 34). FU, follow-up; VHI, vaginal health index.

FIG. 2.

Percentage of subjects pretreatment, at 1 month (1M FU), and at 4 months (4M FU) after the last treatment (a) within and outside of the normal vaginal pH range (3.8–4.5) (n = 34); (b) with sexual dysfunction, as determined by the FSFI score (n = 34). FSFI, female sexual function index.

FIG. 3.

GRAS score distribution for (a) SS and (b) VL: percent of subjects reporting slight (score of 1), moderate (score of 2), or marked (score of 3) improvement at 1 month after the first treatment and 1 and 4 months after the last treatment (FU1 and FU2, respectively, n = 34). GRAS, Global Response Assessment Scale; SS, sexual satisfaction; VL, vaginal laxity.

FIG. 4.

Subject satisfaction score: distribution at 1M post-treatment 1 and 1 month (FU1) and 4 months (FU2) after the last treatment (n = 34).