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Group-based PFMT programme for preventing and/or treating UI in pregnant women: protocol of a randomized controlled feasibility study

BACKGROUND: Urinary incontinence (UI) is a prevalent health problem in women worldwide. Many women experience UI during pregnancy. The National Institute for Health and Care Excellence (NICE) recommended pelvic floor muscle training (PFMT) as the first-line conservative treatment for UI. However, it...

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Autores principales: Yang, Xiaowei, Zhang, Aixia, Zhu, Rong, Sayer, Lynn, Bassett, Sam, Woodward, Sue
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10617193/
https://www.ncbi.nlm.nih.gov/pubmed/37907990
http://dx.doi.org/10.1186/s40814-023-01410-2
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author Yang, Xiaowei
Zhang, Aixia
Zhu, Rong
Sayer, Lynn
Bassett, Sam
Woodward, Sue
author_facet Yang, Xiaowei
Zhang, Aixia
Zhu, Rong
Sayer, Lynn
Bassett, Sam
Woodward, Sue
author_sort Yang, Xiaowei
collection PubMed
description BACKGROUND: Urinary incontinence (UI) is a prevalent health problem in women worldwide. Many women experience UI during pregnancy. The National Institute for Health and Care Excellence (NICE) recommended pelvic floor muscle training (PFMT) as the first-line conservative treatment for UI. However, it is not widely implemented due to the limited number of healthcare trainers. Group-based PFMT has been used with older women and a limited number of maternity studies. But the effectiveness of the group-based PFMT needs to be investigated because the overall quality of the studies is low. Therefore, this study aims to assess the feasibility of delivering a group-based PFMT programme for pregnant women in Nanjing city. METHODS: This feasibility study will be conducted in Nanjing Maternity and Child Health Care Hospital in China, using a mixed methods design to investigate the feasibility and acceptability of delivering group-based PFMT to pregnant women. Pregnant women with or without the symptoms of UI will be included. This study aims to recruit 48 pregnant women with 24 in each arm. Participants will receive either the group-based PFMT delivered by a midwife or usual antenatal care which includes only verbal instruction on PFMT. The study will assess the completion rates, acceptability of outcome measures, recruitment and retention rate and calculate an appropriate sample size for a future study. DISCUSSION: The results of this study will inform the design and implementation of a definitive randomized clinical trial to explore the effectiveness of the intervention. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05242809. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40814-023-01410-2.
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spelling pubmed-106171932023-11-01 Group-based PFMT programme for preventing and/or treating UI in pregnant women: protocol of a randomized controlled feasibility study Yang, Xiaowei Zhang, Aixia Zhu, Rong Sayer, Lynn Bassett, Sam Woodward, Sue Pilot Feasibility Stud Study Protocol BACKGROUND: Urinary incontinence (UI) is a prevalent health problem in women worldwide. Many women experience UI during pregnancy. The National Institute for Health and Care Excellence (NICE) recommended pelvic floor muscle training (PFMT) as the first-line conservative treatment for UI. However, it is not widely implemented due to the limited number of healthcare trainers. Group-based PFMT has been used with older women and a limited number of maternity studies. But the effectiveness of the group-based PFMT needs to be investigated because the overall quality of the studies is low. Therefore, this study aims to assess the feasibility of delivering a group-based PFMT programme for pregnant women in Nanjing city. METHODS: This feasibility study will be conducted in Nanjing Maternity and Child Health Care Hospital in China, using a mixed methods design to investigate the feasibility and acceptability of delivering group-based PFMT to pregnant women. Pregnant women with or without the symptoms of UI will be included. This study aims to recruit 48 pregnant women with 24 in each arm. Participants will receive either the group-based PFMT delivered by a midwife or usual antenatal care which includes only verbal instruction on PFMT. The study will assess the completion rates, acceptability of outcome measures, recruitment and retention rate and calculate an appropriate sample size for a future study. DISCUSSION: The results of this study will inform the design and implementation of a definitive randomized clinical trial to explore the effectiveness of the intervention. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05242809. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40814-023-01410-2. BioMed Central 2023-10-31 /pmc/articles/PMC10617193/ /pubmed/37907990 http://dx.doi.org/10.1186/s40814-023-01410-2 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This 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
Yang, Xiaowei
Zhang, Aixia
Zhu, Rong
Sayer, Lynn
Bassett, Sam
Woodward, Sue
Group-based PFMT programme for preventing and/or treating UI in pregnant women: protocol of a randomized controlled feasibility study
title Group-based PFMT programme for preventing and/or treating UI in pregnant women: protocol of a randomized controlled feasibility study
title_full Group-based PFMT programme for preventing and/or treating UI in pregnant women: protocol of a randomized controlled feasibility study
title_fullStr Group-based PFMT programme for preventing and/or treating UI in pregnant women: protocol of a randomized controlled feasibility study
title_full_unstemmed Group-based PFMT programme for preventing and/or treating UI in pregnant women: protocol of a randomized controlled feasibility study
title_short Group-based PFMT programme for preventing and/or treating UI in pregnant women: protocol of a randomized controlled feasibility study
title_sort group-based pfmt programme for preventing and/or treating ui in pregnant women: protocol of a randomized controlled feasibility study
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10617193/
https://www.ncbi.nlm.nih.gov/pubmed/37907990
http://dx.doi.org/10.1186/s40814-023-01410-2
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