Microablative radiofrequency in overactive bladder women: a randomized clinical trial

Abstract

Objective: To evaluate the effect of RF on urinary, vaginal and sexual symptoms in women withoveractive bladder (OAB). Methodology: We will evaluated 140 climacteric women (45-65 yearsold) with OAB or urgency urinary incontinence who are not using medication. We will randomizedand allocated the OAB women into 2 treatment groups: 1. RF Group with monthly sessions for 3months, 2. SHAM Group (application of treatment without contact between the needles and thevaginal mucosa) with monthly sessions for 3 months. Urinary, vaginal and sexual symptoms willbe assessed using specific questionnaires validated for the Portuguese language: InternationalConsultation on Incontinence Questionnaire Short Form, Overactive Bladder and VaginalSymptoms. To assess voiding habits, we will applied voiding diary. To evaluate the function ofthe pelvic floor musculature, we will perfom palpation will be performed. Vaginal trophism willbe evaluated through the analysis of cytology of the vaginal wall and the evaluation of vaginalhealth through the Vaginal Health Index. We will collect the data in two moments: pre-treatmentand 30 days after the end of treatment. Comparison and correlation analyzes of data obtained fromstatistical tests: Kolmogorov-Smirnov (sample normality), comparative analyzes between groups,Analysis of Variance (normal distribution) or the Kruskal-Wallis test (absence of normaldistribution) , Pearson or Spearman tests will be used for correlational analyses, for categoricalvariables the chi-square test or Fisher's exact test and for intragroup evaluation the Wilcoxon testand Student's t test (paired samples). In order to obtain the estimation of the group interactioneffect versus time, we will use the method of analysis of variance for repeated measures(ANOVA). (AU)