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

Abstract Introduction Pelvic floor muscle training (PFMT) exercises and neuromuscular electrical stimulation (NMES) are described as conservative interventions to prevent or treat female stress urinary incontinence (SUI). However, it has not been described yet the effect of PFMT associated to intrav...

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Autores principales:	Bianca Manzan Reis, Jordana Barbosa da Silva, Ana Paula Rodrigues Rocha, Richard Eloin Liebano, Patricia Driusso
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Urinary incontinence Physical therapy specialty Costs and cost analysis Women’s health Pelvic floor Clinical protocols Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/c063a915d2dc4c69b467507368e397d7
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spelling	oai:doaj.org-article:c063a915d2dc4c69b467507368e397d72021-11-21T12:31:30ZIntravaginal electrical stimulation associated with pelvic floor muscle training for women with stress urinary incontinence: study protocol for a randomized controlled trial with economic evaluation10.1186/s13063-021-05781-w1745-6215https://doaj.org/article/c063a915d2dc4c69b467507368e397d72021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05781-whttps://doaj.org/toc/1745-6215Abstract Introduction Pelvic floor muscle training (PFMT) exercises and neuromuscular electrical stimulation (NMES) are described as conservative interventions to prevent or treat female stress urinary incontinence (SUI). However, it has not been described yet the effect of PFMT associated to intravaginal NMES which evaluated the cost-effectiveness and cost-utility of treating. Aims To evaluate the effects of intravaginal NMES associated with the PFMT protocol on urinary loss and quality of life in women with SUI and to evaluate the cost-effectiveness and cost-utility and pelvic floor muscle in women with SUI. Methods Randomized controlled trial study with economic evaluation. Inclusion criteria are woman (biological), aged ≥ 18 years old and with a report of SUI ≥ once/week. Exclusion criteria are presence of vaginal or urinary infection, virginity, being in the gestational or puerperium period, or neurological disease. Participants will undergo physical therapy assessment and intervention: anamnesis, pelvic floor muscle assessment by vaginal palpation and manometry (PeritronTM), questionnaires (Short-Form 6 Dimensions—Brazil (SF-6D), King's Health Questionnaire (KHQ) and King´s Health Questionnaire for Scoring Algorithm), health costs, and voiding diary. Participants will be randomly allocated into 3 groups: CG (control group), IG 1 (intervention group 1, PFMT), and IG2 (intervention group 2, PFMT + NMES). The statistical analysis will be performed by intention to treat, and multivariate analysis of mixed effects will be used to compare outcomes. Effect size measurements will be calculated and will be provided by Cohen’s d test. A significance level of 5% will be adopted. Additionally, the incremental cost-effectiveness and incremental cost-utility ratios will be used. Discussion This protocol can corroborate with the literature in order to identify the effect of techniques, based on the possibility of confirming the hypothesis that the NMES associated with PFMT performed concurrently will be the best treatment option; considering the effectiveness, cost-effectiveness, and cost-utility analysis, it will be used as an option for optimization of the treatment of SUI. Trial registration Brazilian Registry of Clinical Trials (ReBEC) ID: RBR-6gtzg4 . Registered on September 3, 2019.Bianca Manzan ReisJordana Barbosa da SilvaAna Paula Rodrigues RochaRichard Eloin LiebanoPatricia DriussoBMCarticleUrinary incontinencePhysical therapy specialtyCosts and cost analysisWomen’s healthPelvic floorClinical protocolsMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-13 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Urinary incontinence Physical therapy specialty Costs and cost analysis Women’s health Pelvic floor Clinical protocols Medicine (General) R5-920
spellingShingle	Urinary incontinence Physical therapy specialty Costs and cost analysis Women’s health Pelvic floor Clinical protocols Medicine (General) R5-920 Bianca Manzan Reis Jordana Barbosa da Silva Ana Paula Rodrigues Rocha Richard Eloin Liebano Patricia Driusso 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
description	Abstract Introduction Pelvic floor muscle training (PFMT) exercises and neuromuscular electrical stimulation (NMES) are described as conservative interventions to prevent or treat female stress urinary incontinence (SUI). However, it has not been described yet the effect of PFMT associated to intravaginal NMES which evaluated the cost-effectiveness and cost-utility of treating. Aims To evaluate the effects of intravaginal NMES associated with the PFMT protocol on urinary loss and quality of life in women with SUI and to evaluate the cost-effectiveness and cost-utility and pelvic floor muscle in women with SUI. Methods Randomized controlled trial study with economic evaluation. Inclusion criteria are woman (biological), aged ≥ 18 years old and with a report of SUI ≥ once/week. Exclusion criteria are presence of vaginal or urinary infection, virginity, being in the gestational or puerperium period, or neurological disease. Participants will undergo physical therapy assessment and intervention: anamnesis, pelvic floor muscle assessment by vaginal palpation and manometry (PeritronTM), questionnaires (Short-Form 6 Dimensions—Brazil (SF-6D), King's Health Questionnaire (KHQ) and King´s Health Questionnaire for Scoring Algorithm), health costs, and voiding diary. Participants will be randomly allocated into 3 groups: CG (control group), IG 1 (intervention group 1, PFMT), and IG2 (intervention group 2, PFMT + NMES). The statistical analysis will be performed by intention to treat, and multivariate analysis of mixed effects will be used to compare outcomes. Effect size measurements will be calculated and will be provided by Cohen’s d test. A significance level of 5% will be adopted. Additionally, the incremental cost-effectiveness and incremental cost-utility ratios will be used. Discussion This protocol can corroborate with the literature in order to identify the effect of techniques, based on the possibility of confirming the hypothesis that the NMES associated with PFMT performed concurrently will be the best treatment option; considering the effectiveness, cost-effectiveness, and cost-utility analysis, it will be used as an option for optimization of the treatment of SUI. Trial registration Brazilian Registry of Clinical Trials (ReBEC) ID: RBR-6gtzg4 . Registered on September 3, 2019.
format	article
author	Bianca Manzan Reis Jordana Barbosa da Silva Ana Paula Rodrigues Rocha Richard Eloin Liebano Patricia Driusso
author_facet	Bianca Manzan Reis Jordana Barbosa da Silva Ana Paula Rodrigues Rocha Richard Eloin Liebano Patricia Driusso
author_sort	Bianca Manzan Reis
title	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
title_short	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
title_full	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
title_fullStr	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
title_full_unstemmed	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
title_sort	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
publisher	BMC
publishDate	2021
url	https://doaj.org/article/c063a915d2dc4c69b467507368e397d7
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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

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