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Different weekly frequencies of pelvic floor muscle training for women with stress urinary incontinence: a randomized controlled trial with economic evaluation

Abstract

Pelvic floor muscle training (TMAP) is considered the first line of treatment to prevent or treat female stress urinary incontinence (SUI). Few studies have evaluated the cost-effectiveness and cost-effectiveness of SUI treatment, and these studies mostly refer to costs for surgical or drug treatment. Aim: To verify the effectiveness and cost-utility of different weekly frequencies of the training of the pelvic floor musculature for women with SUI. Methods: Randomized controlled trial, with cost-effectiveness and cost-utility analyzes. They will be adopted for social inclusion: being a woman (biological), equal or superior to 18 years and report of urinary loss to effort. Exclusion criteria will be: latex allergy, vaginal or urinary infection, virginity, being in the gestational period or pregnant puerperium or neurological disease. The study will be submitted to the Ethics and Research Committee of the Federal University of São Carlos and will be registered in REBEC. After receiving the information about the project and signing the informed consent, the participants will be submitted to physical therapy evaluation and intervention. The evaluations will consist of: evaluation of the pelvic floor musculature using the Modified Oxford Scale and Manometer (Peritron), Short-Form 6 Dimensions Questionnaire (KHQ) and King's Health Questionnaire Questionnaire for Scoring Algorithm, Health Costs and Voiding Journal. The intervention will be performed by the following protocol in standing, sitting, kneeling and lying positions (1 set for each position), 8-12 repetitions, sustained contraction for 6-8 seconds (after each repetition 3 to 4 rapid contractions will be added ) and with relaxation of 6 seconds between contractions. Participants will be randomly assigned to three groups: Group 1: TMAP 1 time / week; Group 2: TMAP 2 times / week and Group 3: guidance booklet. Statistical Analysis: For descriptive statistics, mean values, standard deviation and 95% confidence intervals will be used. The multivariate analysis will establish comparisons. Effect size measurements, Cohen's d test, will identify the magnitudes of observed differences, being low (0.10), moderate (0.25) or high (.40). Statistical significance less than 5%. In addition, the reasons for incremental cost-effectiveness and incremental cost-utility will be used. (AU)

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Scientific publications
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
RUBIO ALEM, MICHELE ELISABETE; DA SILVA, JORDANA BARBOSA; SARTORATO BELEZA, ANA CAROLINA; CHAVES, THAIS CRISTINA; DRIUSSO, PATRICIA. Cross-cultural adaptation and measurement property analysis of the Brazilian Portuguese version of the Three Incontinence Questionnaire. INTERNATIONAL UROGYNECOLOGY JOURNAL, JAN 2022. Web of Science Citations: 0.
REIS, BIANCA MANZAN; DA SILVA, JORDANA BARBOSA; RODRIGUES ROCHA, ANA PAULA; LIEBANO, RICHARD ELOIN; DRIUSSO, PATRICIA. Intravaginal electrical stimulation associated with pelvic floor muscle training for women with stress urinary incontinence: study protocol for a randomized controlled trial with economic evaluation. Trials, v. 22, n. 1 NOV 20 2021. Web of Science Citations: 0.
PADILHA, JULIANA FALCAO. Intra- and inter-rater reliability of urethral mobility measurement by ultrasound in women: a cross-section study. INTERNATIONAL UROGYNECOLOGY JOURNAL, v. 32, n. 1 JUN 2020. Web of Science Citations: 0.

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