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Effectiveness of repetitive transcranial magnetic stimulation against poststroke urinary incontinence: a study protocol for a randomized controlled trial
BACKGROUND AND PURPOSE: Poststroke urinary incontinence (PSI) is prevalent in stroke survivors, and high-quality evidence is required to guide clinical practice. Previous studies have demonstrated the curative effect of repetitive transcranial magnetic stimulation (rTMS) for urinary incontinence in...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9375329/ https://www.ncbi.nlm.nih.gov/pubmed/35964135 http://dx.doi.org/10.1186/s13063-022-06535-y |
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author | Jiang, Wei Tang, Wen Song, Yunling Feng, Yali Zhou, Yuesan Li, Lang Tan, Botao |
author_facet | Jiang, Wei Tang, Wen Song, Yunling Feng, Yali Zhou, Yuesan Li, Lang Tan, Botao |
author_sort | Jiang, Wei |
collection | PubMed |
description | BACKGROUND AND PURPOSE: Poststroke urinary incontinence (PSI) is prevalent in stroke survivors, and high-quality evidence is required to guide clinical practice. Previous studies have demonstrated the curative effect of repetitive transcranial magnetic stimulation (rTMS) for urinary incontinence in individuals with multiple sclerosis (MS), Parkinson’s disease (PD), and spinal cord injury (SCI). Here, we describe the protocol for a randomized controlled trial to evaluate the efficacy and safety of low-frequency rTMS on the contralesional primary motor cortex (M1) for the treatment of PSI. METHODS AND ANALYSIS: In this single-centre randomized controlled trial for poststroke urinary incontinence, a total of 140 eligible patients will be randomly allocated into two groups. The rTMS group (n = 70) will receive low-frequency rTMS at the M1 along with routine medical care, while the control group will receive sham rTMS along with routine medical care. All participants will undergo 20 treatment sessions, five times a week for 4 weeks. The primary outcome measures will be the changes in the urodynamic test at baseline versus 4 weeks after intervention. The secondary outcomes include the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF), Overactive Bladder Symptom Score (OABSS), and pelvic floor muscle function. ETHICS AND DISSEMINATION: The Institutional Review Board and Hospital Research Ethics Committee of the Second Affiliated Hospital of Chongqing Medical University approved this trial, and the approval number is No. 2020-153. All methods will be carried out in accordance with the principles of the Declaration of Helsinki and relevant ethical guidelines covering informed consent, confidentiality, and data storage. After the study had been thoroughly described to the participants by a physician, all participants will provide written informed consent indicating their willingness to participate. The results will be disseminated to most of the population, including participants, researchers, healthcare providers, and sponsors. TRIAL REGISTRATION: URL: https://www.chictr.org.cn; Unique identifier: ChiCTR2100042688. Date of Registration: 2021-01-26. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06535-y. |
format | Online Article Text |
id | pubmed-9375329 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-93753292022-08-14 Effectiveness of repetitive transcranial magnetic stimulation against poststroke urinary incontinence: a study protocol for a randomized controlled trial Jiang, Wei Tang, Wen Song, Yunling Feng, Yali Zhou, Yuesan Li, Lang Tan, Botao Trials Study Protocol BACKGROUND AND PURPOSE: Poststroke urinary incontinence (PSI) is prevalent in stroke survivors, and high-quality evidence is required to guide clinical practice. Previous studies have demonstrated the curative effect of repetitive transcranial magnetic stimulation (rTMS) for urinary incontinence in individuals with multiple sclerosis (MS), Parkinson’s disease (PD), and spinal cord injury (SCI). Here, we describe the protocol for a randomized controlled trial to evaluate the efficacy and safety of low-frequency rTMS on the contralesional primary motor cortex (M1) for the treatment of PSI. METHODS AND ANALYSIS: In this single-centre randomized controlled trial for poststroke urinary incontinence, a total of 140 eligible patients will be randomly allocated into two groups. The rTMS group (n = 70) will receive low-frequency rTMS at the M1 along with routine medical care, while the control group will receive sham rTMS along with routine medical care. All participants will undergo 20 treatment sessions, five times a week for 4 weeks. The primary outcome measures will be the changes in the urodynamic test at baseline versus 4 weeks after intervention. The secondary outcomes include the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF), Overactive Bladder Symptom Score (OABSS), and pelvic floor muscle function. ETHICS AND DISSEMINATION: The Institutional Review Board and Hospital Research Ethics Committee of the Second Affiliated Hospital of Chongqing Medical University approved this trial, and the approval number is No. 2020-153. All methods will be carried out in accordance with the principles of the Declaration of Helsinki and relevant ethical guidelines covering informed consent, confidentiality, and data storage. After the study had been thoroughly described to the participants by a physician, all participants will provide written informed consent indicating their willingness to participate. The results will be disseminated to most of the population, including participants, researchers, healthcare providers, and sponsors. TRIAL REGISTRATION: URL: https://www.chictr.org.cn; Unique identifier: ChiCTR2100042688. Date of Registration: 2021-01-26. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06535-y. BioMed Central 2022-08-13 /pmc/articles/PMC9375329/ /pubmed/35964135 http://dx.doi.org/10.1186/s13063-022-06535-y Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Jiang, Wei Tang, Wen Song, Yunling Feng, Yali Zhou, Yuesan Li, Lang Tan, Botao Effectiveness of repetitive transcranial magnetic stimulation against poststroke urinary incontinence: a study protocol for a randomized controlled trial |
title | Effectiveness of repetitive transcranial magnetic stimulation against poststroke urinary incontinence: a study protocol for a randomized controlled trial |
title_full | Effectiveness of repetitive transcranial magnetic stimulation against poststroke urinary incontinence: a study protocol for a randomized controlled trial |
title_fullStr | Effectiveness of repetitive transcranial magnetic stimulation against poststroke urinary incontinence: a study protocol for a randomized controlled trial |
title_full_unstemmed | Effectiveness of repetitive transcranial magnetic stimulation against poststroke urinary incontinence: a study protocol for a randomized controlled trial |
title_short | Effectiveness of repetitive transcranial magnetic stimulation against poststroke urinary incontinence: a study protocol for a randomized controlled trial |
title_sort | effectiveness of repetitive transcranial magnetic stimulation against poststroke urinary incontinence: a study protocol for a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9375329/ https://www.ncbi.nlm.nih.gov/pubmed/35964135 http://dx.doi.org/10.1186/s13063-022-06535-y |
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