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.
ABSTRACT
INTRODUCTION: The use of energy-based devices for the treatment of vaginal laxity, orgasmic dysfunction, and stress incontinence, such as minimally ablative fractional laser and radiofrequency, is gaining momentum. This review aims to answer clinical questions on the application of energy-based devices for feminine genital rejuvenation. METHODS: The target group includes physicians involved in esthetic medicine and feminine genital rejuvenation. A literature review was conducted on technologies in use for feminine rejuvenation to explore their safety, efficacy, tolerability, patient satisfaction, and clinical usability. A panel of physicians with clinical experience conducting these types of treatment reviewed and discussed the results of the literature search and gave clinical evidence-based recommendations. RESULTS: Energy-based devices may induce wound healing, stimulating new collagen, and elastin fiber formation. Radiofrequency treatment may also increase small nerve fiber density in the papillary dermis, improving nerve sensitivity, sexual function, including arousal and orgasmic dysfunction. Both minimally ablative fractional laser and radiofrequency has been shown to be effective when treating mild to moderate primary or secondary vulvovaginal laxity and associated secondary conditions. These treatments are reported to be safe, effective, and well tolerated with a rapid return to activities of daily living. CONCLUSIONS: As this is an evolving medical field, clinical evidence often lacks robustness. Studies and clinical experience suggest that feminine genital rejuvenation using energy-based devices seems an attractive option for patients with mild-to-moderate medical conditions. The treatment can be safely and effectively delivered by trained staff as part of the comprehensive care, that is, currently available to women.
