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

• Grant number: 20/03060-8
• Support Opportunities: Regular Research Grants
• Duration: July 01, 2021 - December 31, 2023
• Field of knowledge: Health Sciences - Medicine - Maternal and Child Health
• Principal Investigator: Adriana Orcesi Pedro
• Grantee: Adriana Orcesi Pedro
• Host Institution: Centro de Atenção Integral à Saúde da Mulher (CAISM). Hospital da Mulher Professor Doutor José Aristodemo Pinotti. Universidade Estadual de Campinas (UNICAMP). Campinas , SP, Brazil
• Associated researchers: Anna Valéria Gueldini de Moraes ; Lucia Helena Simões da Costa Paiva

Abstract

Genitourinary syndrome of menopause (GSM) is a highly prevalent medical condition associated with estrogen deficiency, involving changes to the labia, introitus, clitoris, vagina, urethra, and bladder. Vulvovaginal atrophy is a component of GSM. GSM is a highly prevalent medical condition with adverse effects on the health and quality of life of midlife women. There are many effective treatment options, including hormonal and nonhormonal therapy. Low-dose vaginal estrogen therapy is very effective. Women with contraindications to the standardized treatments of GSM, or who did not show significant improvement in symptoms with conventional non-hormonal treatments and even those who prefer not to use them, continue to suffer the negative consequences of hypoestrogenism, with adverse effects on the health and quality of life. The scarcity of clinical trials with alternative, innovative and long-lasting techniques for the treatment of urogenital atrophy perpetuates the suffering of the affected population, which remains undertreated. Physical methods can be applied clinically to promote a regenerative process in the vaginal mucosa. Among them, the vaginal focused monopolar radiofrequency stands out, a non-ablative method, which consists of the application of electromagnetic waves through a vaginal probe, promoting controlled heating of the underlying mucosa, in order to stimulate neovascularization and neocolagenesis, promoting the restoration of the atrophic mucosa. In order to compare the effectiveness of vaginal focused monopolar radiofrequency, vaginal estrogenic therapy and vaginal moisturizer in the treatment of SGM, an open randomized clinical trial will be conducted with 120 postmenopausal women, aged between 30 and 75 years, followed up at the CAISM Menopausal's Medical Clinic. Women with at least 12 months of amenorrhea who have clinical complaints of urogenital atrophy will be included, randomly distributed in the following groups (n = 30): Radiofrequency Group I Premature Menopause (women between 30 and 45 years old, who had premature ovarian failure, regardless use of hormonal therapy), Radiofrequency Group II (women between 45 and 75 years old, not using hormone therapy), Vaginal Estrogen Group and Vaginal Hydrating Group. Subjective parameters will be assessed through Visual Analogue Scale (VAS), clinical parameters through physical examination, vaginal health questionnaire (VHI - Vaginal Health Index), urinary incontinence questionnaires (ICIQ-OAB and ICIQ-SF), sexual dysfunction questionnaire (FSFI), and histopathological analysis. All patients will be followed for 4 months, with reassessments of subjective and clinical parameters in 3 stages: baseline (D0), 60 days (D1) and 120 days (D2). The histopathological analysis will be done in 2 stages: before the first application and 4 months after the first application. The initial statistical analysis will be descriptive, through the measures of frequency, means and standard deviations. For comparison of categorical variables, the Chi-Square or Fisher tests will be used. Comparison will be made of intragroup parameters studied over time and between groups (RFMV I, II RFMV, vaginal estrogen vaginal moisturizer) by ANOVA. (AU)