Identifying continence options after stroke (ICONS): A cluster randomised controlled feasibility trial
Thomas, Lois H., Watkins, Caroline Leigh, Sutton, Christopher J., Forshaw, Denise, Leathley, Michael J., French, Beverley, Burton, Christopher R., Cheater, Francine, Roe, Brenda, Britt, David, Booth, Jo, McColl, Elaine, Carter, Bernadette, Rodgers, Helen, Brittain, Katie, Walker, Andrew, Barrett, James, Whiteley, Gemma, Brand, Pat, ... Wright, Jean 2014. Identifying continence options after stroke (ICONS): A cluster randomised controlled feasibility trial. Trials. 15 (1), pp. 1 - 15. https://doi.org/10.1186/1745-6215-15-509
|Authors||Thomas, Lois H., Watkins, Caroline Leigh, Sutton, Christopher J., Forshaw, Denise, Leathley, Michael J., French, Beverley, Burton, Christopher R., Cheater, Francine, Roe, Brenda, Britt, David, Booth, Jo, McColl, Elaine, Carter, Bernadette, Rodgers, Helen, Brittain, Katie, Walker, Andrew, Barrett, James, Whiteley, Gemma, Brand, Pat, Griffiths, May, Helvin, Philip, James, Brian, Pearl, Gill, Whitewood, Jane, Vella, Jacqui, Childs, Audrey, Childs, Richard, Crosby, Sean, Hall, Steve, Lewin, Anj, Royle, Liz, Scott, Carole and Wright, Jean|
Background: Urinary incontinence ( UI ) affects half of patients hospitalised after stroke and is often poorly managed. Cochrane systematic reviews have shown some positive impact of conservative interventions ( such as bladder training ) in reducing UI, but their effectiveness has not been demonstrated with stroke patients. Methods: We conducted a cluster randomised controlled feasibility trial of a systematic voiding programme ( SVP ) for the management of UI after stroke. Stroke services were randomised to receive SVP ( n = 4 ), SVP plus supported implementation ( SVP+, n = 4 ), or usual care ( UC, n = 4 ). Feasibility outcomes were participant recruitment and retention. The main effectiveness outcome was presence or absence of UI at six and 12 weeks post-stroke. Additional effectiveness outcomes included were the effect of the intervention on different types of UI, continence status at discharge, UI severity, functional ability, quality of life, and death. Results: It was possible to recruit patients ( 413; 164 SVP, 125 SVP+, and 124 UC ) and participant retention was acceptable ( 85% and 88% at six and 12 weeks, respectively ). There was no suggestion of a beneficial effect on the main outcome at six ( SVP versus UC: odds ratio ( OR ) 0.94, 95% CI: 0.46 to 1.94; SVP+ versus UC: OR: 0.62, 95% CI: 0.28 to 1.37 ) or 12 weeks ( SVP versus UC: OR: 1.02, 95% CI: 0.54 to 1.93; SVP+ versus UC: OR: 1.06, 95% CI: 0.54 to 2.09 ). No secondary outcomes showed a strong suggestion of clinically meaningful improvement in SVP and/or SVP+ arms relative to UC at six or 12 weeks. However, at 12 weeks both intervention arms had higher estimated odds of continence than UC for patients with urge incontinence. Conclusions: The trial has met feasibility outcomes of participant recruitment and retention. It was not powered to demonstrate effectiveness, but there is some evidence of a potential reduction in the odds of specific types of incontinence. A full trial should now be considered. Trial registration: ISRCTN Registry, ISRCTN08609907, date of registration: 7 July 2010.
|Keywords||cluster randomised controlled trial; feasibility; stroke; urinary incontinence|
|Journal citation||15 (1), pp. 1 - 15|
|Publisher||Biomed Central Ltd|
|Digital Object Identifier (DOI)||https://doi.org/10.1186/1745-6215-15-509|
|Open access||Open access|
|Page range||1 - 15|
© 2014 Thomas et al.; licensee BioMed Central. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
|Place of publication||United Kingdom|
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