Effect of fractional microablative radiofrequency and pelvic floor muscle training in the treatment of women with of vaginal laxity: randomized clinical trial

Abstract

Vaginal laxity is defined as a complaint of excessive vaginal flaccidity. It presents prevalence of 24% and seems to be associated with young age, vaginal deliveries, prolapse symptoms, and objective prolapse, being, therefore, a somatic dysfunction rather than psychogenic. To date, no clinical trial has been developed to evaluate the role of pelvic floor muscle training and radiofrequency in vaginal looseness. Objectives: To compare the effect of fractional microablative radiofrequency (RF) and pelvic floor muscle training (TMAP) in women complaining of vaginal laxity. Methodology: Clinical, randomized, prospective, controlled, parallel and non-blind study. Premenopausal women aged e 18 years, vaginal delivery, with complaints of vaginal laxity will be included. Participants will be divided into two treatment groups: 1 - radiofrequency and 2 - pelvic floor muscle training, with reevaluation in 90 and 180 days. To characterize the research participants, a descriptive analysis of the data will be made. Inferential statistical analysis will be performed from the following statistical tests: Kolmogorov-Smirnov, Variance Analysis, Wilcoxon and Mann-Whitney Test, Pearson or Spearman Test, Chi-square test and Fisher's exact test. Statistical analyses will be performed by the SPSS (Statistical Package for the Social Sciences), adopting a significance level of 5% (p <0.05). Data will also be evaluated by analysis of variance for repeated measurements (ANOVA). If the numerical variables do not present normal distribution, they will be transformed into ranks or stations. (AU)