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

Thomas, L.H. and Watkins, C.L. and Sutton, C.J. and Forshaw, D. and Leathley, M.J. and French, B. and Burton, C.R. and Cheater, F. and Roe, B. and Britt, D. and Booth, J. and McColl, E. (2014) Identifying continence options after stroke (ICONS): a cluster randomised controlled feasibility trial. Trials, 15 (509). DOI: 10.1186/1745-6215-15-509 (In Press)

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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.

Item Type: Article
Subjects: Research Publications
Departments: College of Health and Behavioural Sciences > School of Healthcare Sciences
Date Deposited: 20 Feb 2015 03:33
Last Modified: 23 Sep 2015 02:50
ISSN: 1745-6215
URI: http://e.bangor.ac.uk/id/eprint/3533
Identification Number: DOI: 10.1186/1745-6215-15-509
Publisher: Biomed Central
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