Microablative Fractional Radiofrequency for women with Overactive Bladder: a randomized controlled trial

• Grant number: 24/08594-1
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Effective date (Start): September 01, 2024
• Effective date (End): August 31, 2025
• Field of knowledge: Health Sciences - Medicine - Maternal and Child Health
• Principal Investigator: Cássia Raquel Teatin Juliato
• Grantee: Ana Luisa Zambelli Mesquita de Oliveira
• 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

Abstract

Introduction: Urinary incontinence (UI) and urgency urinary incontinence (UUI) impact the quality of life of women in the climacteric period. Fractional microablative radiofrequency (RF) is an innovative and effective treatment option for urgency symptoms. Objectives: To evaluate the effect of RF on urinary, vaginal, and sexual symptoms in women with overactive bladder. Methodology: 140 climacteric women with overactive bladder or mixed urinary incontinence with a predominance of urgency, who are not undergoing medication treatment, will be evaluated. They will be randomized and allocated into 2 treatment groups: 1. RF Group with monthly sessions for 3 months, 2. SHAM Group (application of treatment without needle contact with the vaginal mucosa, simulating RF) with monthly sessions for 3 months. Urinary, vaginal, and sexual symptoms will be assessed using specific questionnaires validated for the Portuguese language: International Consultation on Incontinence Questionnaire Short Form, International Consultation on Incontinence Questionnaire - Overactive Bladder, International Consultation on Incontinence Questionnaire - Overactive Bladder - quality of life, International Consultation on Incontinence Questionnaire - Vaginal Symptoms. A voiding diary will be used to evaluate voiding habits. Pelvic floor muscle function will be assessed through digital palpation. Vaginal trophism will be evaluated by analyzing vaginal wall cytology, and vaginal health will be assessed using the Vaginal Health Index. Data will be collected at two time points: pre-treatment and 30 days after the end of treatment. Data analysis will be performed using the statistical program SPSS (Statistical Package for the Social Sciences), adopting a significance level of p<0.05. Comparative and correlation analyses of the data obtained from statistical tests will be conducted: Kolmogorov-Smirnov (sample normality), comparative analyses between groups using Analysis of Variance (normal distribution) or the Kruskal-Wallis test (absence of normal distribution), Pearson or Spearman tests for correlation analyses, chi-square tests or Fisher's exact test for categorical variables, and Wilcoxon test and Student's t-test (paired samples) for within-group evaluation. Additionally, repeated measures ANOVA will be used to estimate the interaction effect of group versus time. This is a regular project funded by FAPESP (2013/06165-3). The role of the undergraduate student will be to recruit women, conduct initial and final evaluations, create a database, participate in statistical analysis, and prepare the article. RF will be applied by a gynecologist participating in the study.