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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Bowen, Audrey, Hesketh, Anne, Patchick, Emma, Young, Alys, Davies, Linda, Vail, Andy, Long, Andrew F., Watkins, Caroline, Wilkinson, Mo, Pearl, Gill, Ralph, Matthew A. and Tyrrell, Pippa. (2012). Authors' reply to Enderby, Meteyard, and Thornton. BMJ: British Medical Journal. 345(7874), pp. 1 - 2. https://doi.org/10.1136/bmj.e6023
Mapping vocational rehabilitation services for people with long term neurological conditions: Summary report
Playford, E, Radford, K, Burton, C, Gibson, A, Sweetland, J and Watkins, Caroline. (2011). Mapping vocational rehabilitation services for people with long term neurological conditions: Summary report United Kingdom: Department of Health.
How do marital status and gender affect the PRR to a university degree in Australia?
Wright, Sarah. (2011). How do marital status and gender affect the PRR to a university degree in Australia? Contemporary Issues in Education Research. 4(7), pp. 19 - 32. https://doi.org/10.19030/cier.v4i7.4790
The UK forum for stroke training and the stroke-specific education framework
Watkins, Caroline, Barron, Tracey, Davis, David, Hatton, Steve, Jenkinson, D, Jones, Stephanie, Price, Chris, South, Adrian, Quinn, T and Leathley, M. (2011). The UK forum for stroke training and the stroke-specific education framework. Journal of Paramedic Practice. 3(9), pp. 481 - 482. https://doi.org/10.12968/jpar.2011.3.9.481
Study protocol :iCONS: identifying continence options after stroke: A randomised trial
Thomas, Lois, Watkins, Caroline, French, B, Sutton, C, Forshaw, D, Cheater, F, Roe, B, Leathley, M, Burton, C, McColl, E and Booth, J. (2011). Study protocol :iCONS: identifying continence options after stroke: A randomised trial. Trials. 12, pp. 1 - 10. https://doi.org/10.1186/1745-6215-12-131
The 12-month effects of early motivational interviewing after acute stroke :A randomized controlled trial
Watkins, Caroline, Wathan, J, Leathley, M, Auton, M, Deans, Carol, Dickinson, H, Jack, Cathy, Sutton, C, Van Den Broek, M and Lightbody, C. (2011). The 12-month effects of early motivational interviewing after acute stroke :A randomized controlled trial. Stroke: a journal of cerebral circulation. 42(7), pp. 1956 - 1961. https://doi.org/10.1161/STROKEAHA.110.602227
Combined conservative interventions for urge, stress or mixed incontinence in adults (protocol)
French, Beverley, Thomas, Lois H., Sutton, Christopher J., Booth, J., Brittain, Katie, Burton, Christopher R., Cheater, Francine, Roe, Brenda, Hay-Smith, E. Jean C., McAdam, J. J. and Watkins, Caroline. (2010). Combined conservative interventions for urge, stress or mixed incontinence in adults (protocol). Cochrane Database of Systematic Reviews. https://doi.org/10.1002/14651858.CD008910
Changing stroke mortality trends in middle-aged people : An age-period-cohort analysis of routine mortality data in persons aged 40 to 69 in England
Sutton, C, Marsden, J, Watkins, Caroline, Leathley, M and Dey, P. (2010). Changing stroke mortality trends in middle-aged people : An age-period-cohort analysis of routine mortality data in persons aged 40 to 69 in England. Journal of Epidemiology and Community Health. 64(6), pp. 523 - 529. https://doi.org/10.1136/jech.2008.086785
What are the alternatives to student loans in higher education funding?
Stokes, Tony and Wright, Sarah. (2010). What are the alternatives to student loans in higher education funding? Contemporary Issues in Education Research. 3(1), pp. 19 - 30.
Does repetitive task training improve functional activity after stroke? : A Cochrane systematic review and meta-analysis
French, Beverley, Thomas, Lois, Leathley, Michael, Sutton, Christopher, McAdam, Joanna, Forster, Anne, Langhorne, Peter, Price, Chris, Walker, Annette and Watkins, Caroline. (2010). Does repetitive task training improve functional activity after stroke? : A Cochrane systematic review and meta-analysis. Journal of Rehabilitation Medicine. 42(1), pp. 9 - 15. https://doi.org/10.2340/16501977-0473
Very early rehabilitation or intensive telemetry after stroke : A pilot randomised trial
Langhorne, P, Stott, D, Knight, A, Bernhardt, Julie, Barer, D and Watkins, Caroline. (2010). Very early rehabilitation or intensive telemetry after stroke : A pilot randomised trial. Cerebrovascular Diseases. 29(4), pp. 352 - 360. https://doi.org/10.1159/000278931
Are university students paying too much for their education in Australia?
Stokes, Tony and Wright, Sarah. (2010). Are university students paying too much for their education in Australia? Journal of Australian Political Economy. 65(2), pp. 5 - 27.
Does repetitive task training improve functional activity after stroke? : A Cochrane systematic review and meta-analysis
French, Beverley, Thomas, Lois, Leathley, Michael, Sutton, Christopher, McAdam, Joanna, Forster, Anne, Langhorne, Peter, Price, Chris, Walker, Annette and Watkins, Caroline. (2010). Does repetitive task training improve functional activity after stroke? : A Cochrane systematic review and meta-analysis. Journal of Rehabilitation Medicine. 42(1), pp. 9 - 15. https://doi.org/10.2340/16501977-0473
Stroke knowledge and awareness : An integrative review of the evidence
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 In G. Castledine and A. Close (Ed.). Oxford handbook of adult nursing pp. 435 - 484 Oxford University Press. https://doi.org/10.1093/med/9780199231355.003.0013
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 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 Greenacre Educational Publications.