Comparison of the effect of noninvasive radiofrequency with vaginal estrogen and vaginal moisturizer in the treatment of vulvovaginal atrophy in postmenopausal women: a randomized clinical trial

Author(s)

de Moraes, Anna Valeria Gueldini ; Costa-Paiva, Lucia ; da Costa Machado, Helymar ; Maciel, Tayna Figueiredo ; Mariano, Fernanda Viviane ; Pedro, Adriana Orcesi

• Document type: Journal article
• Source: MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY; v. 31, n. 4, p. 15-pg., 2024-04-01.

Abstract

Objective: To compare the effect of noninvasive radiofrequency (RF) with vaginal estrogen (E), and vaginal moisturizer (M) on improving vulvovaginal atrophy (VVA) in women with genitourinary syndrome of menopause. Methods: A total of 32 postmenopausal women who met the inclusion criteria were randomized into three intervention arms to receive one of the following treatments: three sessions of noninvasive RF therapy (RF arm); intravaginal estriol cream 1 mg applied daily for 2 weeks, followed by 1 mg applied two times weekly or 1 mg of estradiol vaginal fast-dissolving film applied daily for 2 weeks, followed by 1 mg applied two times weekly (E arm); and intravaginal moisturizer two times a week (M arm). Assessments at baseline and after 4 months were conducted using Vaginal Health Index score, Vaginal Maturation, visual analog scale for VVA symptoms (dyspareunia, dryness, and burning), and Menopause Rating Scale (MRS) for urogenital symptoms. Vaginal wall biopsies were administered to participants who consented, pretreatment and posttreatment (at baseline and after 4 months of follow-up). Results: After 4 months, the Vaginal Health Index showed an increase of 6.6 points in mean total score in the RF arm, also in the E arm (+7.3 points), with no significant improvement in the M arm (+1.5 points) (interaction effect: RF, E not equal M, P < 0.001). Regarding vaginal maturation, there was a significant increase in superficial cells in the E arm (+31.3), with no significant changes in the RF (+9.3) and M (-0.5) arms (interaction effect: E not equal M, P < 0.001). Vaginal pH decreased significantly in the E arm (-1.25), with a similar response in the RF arm (-1.7), with no significant improvement in the M arm (-0.25) (interaction effect: RF, E not equal M, P < 0.001). There was a significant improvement in the MRS score for VVA symptoms in the three intervention arms, with no predominance of any arm, whereas the improvement in the total MRS score for urogenital symptoms showed a predominance of the RF arm (Delta RF: -7.8; Delta E: -3.5; Delta M: -2.3; RF not equal E, M). According to histopathologic analysis, there was no statistically significant increase in glycogenation (P = 0.691) or epithelial cone height (P = 0.935), despite an increase in the median delta (difference between pretreatment and posttreatment) in the three intervention arms (glycogenation: RF arm Delta = +118.4%; E arm Delta = +130.9%; M arm Delta = +24.9%; epithelial cone height: RF arm Delta = +33.5%; E arm Delta = +18.6%; M arm Delta = +22.3%). Conclusion: The effect of noninvasive RF on the treatment of vulvovaginal symptoms of genitourinary syndrome of menopause was similar to vaginal estrogen, except for hormonal cytology, and superior to vaginal moisturizer, with improvement in some histomorphometric parameters. These findings are promising, especially for the population that cannot or prefers not to use vaginal estrogen therapy. (AU)

• FAPESP's process: 20/03060-8 - Efficacy of vaginal focused monopolar radiofrequency, vaginal estrogenic therapy, or vaginal polyacrylic acid, in the treatment of genitourinary syndrome of menopause (GSM): a randomized clinical trial
• Grantee: Adriana Orcesi Pedro
• Support Opportunities: Regular Research Grants