Identifying continence options after stroke (ICONS): A cluster randomised controlled feasibility trial

Journal article


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
AuthorsThomas, 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
Abstract

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.

Keywordscluster randomised controlled trial; feasibility; stroke; urinary incontinence
Year2014
JournalTrials
Journal citation15 (1), pp. 1 - 15
PublisherBiomed Central Ltd
ISSN1745-6215
Digital Object Identifier (DOI)https://doi.org/10.1186/1745-6215-15-509
Scopus EID2-s2.0-84928653325
Open accessOpen access
Page range1 - 15
Publisher's version
Additional information

© 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 publicationUnited Kingdom
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Jones, Susanne, Jenkinson, A, Leathley, M and Watkins, Caroline 2010. Stroke knowledge and awareness : An integrative review of the evidence. Age and Ageing. 39 (1), pp. 11 - 22. https://doi.org/10.1093/ageing/afp196;10.1093/ageing/afp196
Nursing patients with neurological problems
Watkins, Caroline Leigh 2009. Nursing patients with neurological problems. in: G. Castledine and A. Close (ed.) Oxford handbook of adult nursing United Kingdom: Oxford University Press. pp. 435 - 484
Repetitive task training for improving functional ability after stroke
French, Beverley, Thomas, Lois H., Leathley, Michael John, Sutton, Christopher J., McAdam, Joanna J., Forster, Anne, Langhorne, Peter J., Price, Christopher I.M., Walker, Andrew and Watkins, Caroline L. 2009. Repetitive task training for improving functional ability after stroke. Stroke: a journal of cerebral circulation. 40 (4), pp. 98 - 99. https://doi.org/10.1161/STROKEAHA.108.519553
Psychological intervention poststroke: ready for action?
Watkins, Caroline and French, Beverley 2009. Psychological intervention poststroke: ready for action? Stroke. 40 (9), pp. 2951 - 2952. https://doi.org/10.1161/STROKEAHA.109.562348
An investigation into the equity and efficiency of Australia's higher education system
Wright, Sarah Jean 2008. An investigation into the equity and efficiency of Australia's higher education system. Thesis https://doi.org/10.4226/66/5a95df08c67e7
Treatment of stroke: Acting on the symptoms
Jones, Stephanie, Leathley, Michael J. and Watkins, Caroline Leigh 2008. Treatment of stroke: Acting on the symptoms. Asian Hospital and Healthcare Management.
An investigation into the equity and efficiency of Australia's higher education system
Wright, Sarah Jean 2008. An investigation into the equity and efficiency of Australia's higher education system. Australia: Greenacre Educational Publications.
Treatment of urinary incontinence after stroke in adults (review)
Thomas, Lois H., Cross, S., French, B., Leathley, M. J., Sutton, C. J. and Watkins, Caroline Leigh 2008. Treatment of urinary incontinence after stroke in adults (review). Cochrane Database of Systematic Reviews. https://doi.org/10.1002/14651858.CD004462.pub3
Measuring the social rate of return in public sector labor markets
Stokes, Tony and Wright, Sarah 2008. Measuring the social rate of return in public sector labor markets. Journal of Business and Economics Research. 6 (5), pp. 1 - 15.
Engaging service users in the development of stroke services: An action research study
Jones, Stephanie P., Auton, Malcolm F., Burton, Christopher R. and Watkins, Caroline L. 2008. Engaging service users in the development of stroke services: An action research study. Journal of Clinical Nursing. 17 (10), pp. 1270 - 1279. https://doi.org/10.1111/j.1365-2702.2007.02259.x
Acute stroke management: An online course
Jones, Stephanie, McLoughlin, A. and Watkins, Caroline 2008. Acute stroke management: An online course. Journal of Paramedic Practice: the clinical monthly for emergency care professionals. 3 (6), pp. 322 - 326.
Can early onset bone loss be effectively managed in post-stroke patients? An integrative review of the evidence
Marsden, Jenny, Gibson, Lorna Mary, Lightbody, Catherine Elizabeth, Sharma, Anil Kumar, Siddiqi, Mashood and Watkins, Caroline 2008. Can early onset bone loss be effectively managed in post-stroke patients? An integrative review of the evidence. Age and Ageing. 37 (2), pp. 142 - 150. https://doi.org/10.1093/ageing/afm198
A systematic review of repetitive functional task practice with modelling of resource use, costs and effectiveness
French, Beverley, Leathley, Michael John, Sutton, Christopher J., McAdam, Joanna J., Thomas, Lois H., Forster, A., Langhorne, Peter J., Price, Christopher I.M., Walker, Annette and Watkins, Caroline 2008. A systematic review of repetitive functional task practice with modelling of resource use, costs and effectiveness. Health Technology Assessment. 12 (30), pp. 1 - 140. https://doi.org/10.3310/hta12300
The challenge of attracting and keeping quality teachers in Australian schools
Stokes, Tony and Wright, Sarah 2007. The challenge of attracting and keeping quality teachers in Australian schools. Annual International Business and Economics Research (IBER) and College Teaching and Learning (TLC) Conference. Las Vegas,United States of America: Clute Institute. pp. 1 - 17
The impact of changes in HECS on students from low socio-economic backgrounds
Wright, Sarah Jean 2005. The impact of changes in HECS on students from low socio-economic backgrounds. Australia: Greenacre Educational Publications.