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.
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 4month 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.
Introduction Androgenetic alopecia (AGA) is the most common type of progressive hair loss, and current treatments are limited. Wound healing has been associated with hair regrowth; consequently, its mechanism has been suggested for treatment of hair loss. Nonablative radiofrequency (RF), which induces wound healing mechanisms through thermal damage, has been shown to increase hair growth when applied to the scalp. In this study, we aim to evaluate a specially adapted non‐ablative RF device as a noninvasive, nonsystemic treatment for AGA. Methods An open‐label study was conducted to evaluate the efficacy of a nonablative RF device for treatment of AGA. Patients diagnosed with Hamilton–Norwood Stage 3 or above were recruited and received 10 weekly RF treatment sessions. Hair counts were performed before and after treatment manually by a medical resident. Results Ten male and 10 female subjects were recruited. Hair count, hair density (per cm2), vellus hair density (per cm2), terminal hair density (per cm2), cumulative thickness (mm/cm2), number of follicular units, density of follicular units (per cm2), and average hair per unit increased from before to after treatment. Only the increases in hair count, overall hair density, terminal hair density, cumulative thickness, and average hair count/unit were statistically significant (p < .05). Discussion We observed significant improvement in hair growth in 19 out of 20 patients. Overall, significant improvement was observed in total hair counts, terminal hair counts, hair shaft thickness, and in the number of follicular units. Further clinical research is warranted to further explore nonablative RF for treatment of AGA.
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