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Proper understanding of recurrent stress urinary incontinence treatment in women (PURSUIT): a randomised controlled trial of endoscopic and surgical treatment
BACKGROUND: Women with stress urinary incontinence (SUI) experience urine leakage with physical activity. Currently, the interventional treatments for SUI are surgical, or endoscopic bulking injection(s). However, these procedures are not always successful, and symptoms can persist or come back afte...
| Autores principales: | , , , , , , , , , , , , , , , , , , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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BioMed Central
2022
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9347071/ https://www.ncbi.nlm.nih.gov/pubmed/35922823 http://dx.doi.org/10.1186/s13063-022-06546-9 |
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| author | Clark, L. Fitzgerald, B. Noble, S. MacNeill, S. Paramasivan, S. Cotterill, N. Hashim, H. Jha, S. Toozs-Hobson, P. Greenwell, T. Thiruchelvam, N. Agur, W. White, A. Garner, V. Cobos-Arrivabene, M. Clement, C. Cochrane, M. Liu, Y. Lewis, A. L. Taylor, J. Lane, J. A. Drake, M. J. Pope, C. |
| author_facet | Clark, L. Fitzgerald, B. Noble, S. MacNeill, S. Paramasivan, S. Cotterill, N. Hashim, H. Jha, S. Toozs-Hobson, P. Greenwell, T. Thiruchelvam, N. Agur, W. White, A. Garner, V. Cobos-Arrivabene, M. Clement, C. Cochrane, M. Liu, Y. Lewis, A. L. Taylor, J. Lane, J. A. Drake, M. J. Pope, C. |
| author_sort | Clark, L. |
| collection | PubMed |
| description | BACKGROUND: Women with stress urinary incontinence (SUI) experience urine leakage with physical activity. Currently, the interventional treatments for SUI are surgical, or endoscopic bulking injection(s). However, these procedures are not always successful, and symptoms can persist or come back after treatment, categorised as recurrent SUI. There are longstanding symptoms and distress associated with a failed primary treatment, and currently, there is no consensus on how best to treat women with recurrent, or persistent, SUI. METHODS: A two-arm trial, set in at least 20 National Health Service (NHS) urology and urogynaecology referral units in the UK, randomising 250 adult women with recurrent or persistent SUI 1:1 to receive either an endoscopic intervention (endoscopic bulking injections) or a standard NHS surgical intervention, currently colposuspension, autologous fascial sling or artificial urinary sphincter. The aim of the trial is to determine whether surgical treatment is superior to endoscopic bulking injections in terms of symptom severity at 1 year after randomisation. This primary outcome will be measured using the patient-reported International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI-SF). Secondary outcomes include assessment of longer-term clinical impact, improvement of symptoms, safety, operative assessments, sexual function, cost-effectiveness and an evaluation of patients’ and clinicians’ views and experiences of the interventions. DISCUSSION: There is a lack of high-quality, randomised, scientific evidence for which treatment is best for women presenting with recurrent SUI. The PURSUIT study will benefit healthcare professionals and patients and provide robust evidence to guide further treatment and improve symptoms and quality of life for women with this condition. TRIAL REGISTRATION: International Standard Randomised Controlled Trials Number (ISRCTN) registry ISRCTN12201059. Registered on 09 January 2020 |
| format | Online Article Text |
| id | pubmed-9347071 |
| institution | National Center for Biotechnology Information |
| language | English |
| publishDate | 2022 |
| publisher | BioMed Central |
| record_format | MEDLINE/PubMed |
| spelling | pubmed-93470712022-08-04 Proper understanding of recurrent stress urinary incontinence treatment in women (PURSUIT): a randomised controlled trial of endoscopic and surgical treatment Clark, L. Fitzgerald, B. Noble, S. MacNeill, S. Paramasivan, S. Cotterill, N. Hashim, H. Jha, S. Toozs-Hobson, P. Greenwell, T. Thiruchelvam, N. Agur, W. White, A. Garner, V. Cobos-Arrivabene, M. Clement, C. Cochrane, M. Liu, Y. Lewis, A. L. Taylor, J. Lane, J. A. Drake, M. J. Pope, C. Trials Study Protocol BACKGROUND: Women with stress urinary incontinence (SUI) experience urine leakage with physical activity. Currently, the interventional treatments for SUI are surgical, or endoscopic bulking injection(s). However, these procedures are not always successful, and symptoms can persist or come back after treatment, categorised as recurrent SUI. There are longstanding symptoms and distress associated with a failed primary treatment, and currently, there is no consensus on how best to treat women with recurrent, or persistent, SUI. METHODS: A two-arm trial, set in at least 20 National Health Service (NHS) urology and urogynaecology referral units in the UK, randomising 250 adult women with recurrent or persistent SUI 1:1 to receive either an endoscopic intervention (endoscopic bulking injections) or a standard NHS surgical intervention, currently colposuspension, autologous fascial sling or artificial urinary sphincter. The aim of the trial is to determine whether surgical treatment is superior to endoscopic bulking injections in terms of symptom severity at 1 year after randomisation. This primary outcome will be measured using the patient-reported International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI-SF). Secondary outcomes include assessment of longer-term clinical impact, improvement of symptoms, safety, operative assessments, sexual function, cost-effectiveness and an evaluation of patients’ and clinicians’ views and experiences of the interventions. DISCUSSION: There is a lack of high-quality, randomised, scientific evidence for which treatment is best for women presenting with recurrent SUI. The PURSUIT study will benefit healthcare professionals and patients and provide robust evidence to guide further treatment and improve symptoms and quality of life for women with this condition. TRIAL REGISTRATION: International Standard Randomised Controlled Trials Number (ISRCTN) registry ISRCTN12201059. Registered on 09 January 2020 BioMed Central 2022-08-03 /pmc/articles/PMC9347071/ /pubmed/35922823 http://dx.doi.org/10.1186/s13063-022-06546-9 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 Clark, L. Fitzgerald, B. Noble, S. MacNeill, S. Paramasivan, S. Cotterill, N. Hashim, H. Jha, S. Toozs-Hobson, P. Greenwell, T. Thiruchelvam, N. Agur, W. White, A. Garner, V. Cobos-Arrivabene, M. Clement, C. Cochrane, M. Liu, Y. Lewis, A. L. Taylor, J. Lane, J. A. Drake, M. J. Pope, C. Proper understanding of recurrent stress urinary incontinence treatment in women (PURSUIT): a randomised controlled trial of endoscopic and surgical treatment |
| title | Proper understanding of recurrent stress urinary incontinence treatment in women (PURSUIT): a randomised controlled trial of endoscopic and surgical treatment |
| title_full | Proper understanding of recurrent stress urinary incontinence treatment in women (PURSUIT): a randomised controlled trial of endoscopic and surgical treatment |
| title_fullStr | Proper understanding of recurrent stress urinary incontinence treatment in women (PURSUIT): a randomised controlled trial of endoscopic and surgical treatment |
| title_full_unstemmed | Proper understanding of recurrent stress urinary incontinence treatment in women (PURSUIT): a randomised controlled trial of endoscopic and surgical treatment |
| title_short | Proper understanding of recurrent stress urinary incontinence treatment in women (PURSUIT): a randomised controlled trial of endoscopic and surgical treatment |
| title_sort | proper understanding of recurrent stress urinary incontinence treatment in women (pursuit): a randomised controlled trial of endoscopic and surgical treatment |
| topic | Study Protocol |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9347071/ https://www.ncbi.nlm.nih.gov/pubmed/35922823 http://dx.doi.org/10.1186/s13063-022-06546-9 |
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