Intravaginal electrical stimulation associated with pelvic floor muscle training for women with stress urinary incontinence: randomized controlled trial with economic evaluation

Abstract

Pelvic floor muscle training (PFMT) exercises and electrical stimulation (ES) are described as conservative interventions to prevent or treat female stress urinary incontinence (SUI). However, the effect of PFMT associated to intravaginal ES has not be described yet. Also, few studies have evaluated the cost-effectiveness and cost-utility of treating SUI, and these studies, for the most part, refer to the costs of surgical or drug treatment. The objective of this project will be evaluated the effects of intravaginal ES associated with PFMT protocol on urinary loss, quality of life and muscle function in women with SUI; and, to calculate the cost-effectiveness and cost-utility of the intervention. Methods: This is a randomized controlled trial study with economic evaluation. Inclusion criteria are women (biological), aged equal to or over 18 years old and report of urinary loss on stress. The participants will be randomly divided into group 1 (educational booklet related to PFMT), group 2 (PFMT with physiotherapist supervision once a week) and group 3 (ES + PFMT with physiotherapist supervision once a week). The following outcomes will be evaluated by a blinded assessor at baseline, three, six and 12 months after randomization: pelvic floor muscle assessment by vaginal palpation and manometry (Peritron), urinary loss (voiding diary), health-related quality of life by Short-Form 6 Dimensions, King's Health Questionnaire and King´s Health Questionnaire for Scoring Algorithm; and health costs about urinary incontinence. (AU)