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

Journal article


Thomas, L.H., Watkins, C.L., Sutton, C.J., Forshaw, D., Leathley, M.J., French, B., Burton, C., Cheater, F., Roe, B., Britt, D., Booth, J., McColl, E., The ICONS Project Team and The ICONS Patient, Public and Carer Involvement Groups 2014. Identifying continence options after stroke (ICONS): a cluster randomised controlled feasibility trial. Trials. 15 (509).
AuthorsThomas, L.H., Watkins, C.L., Sutton, C.J., Forshaw, D., Leathley, M.J., French, B., Burton, C., Cheater, F., Roe, B., Britt, D., Booth, J., McColl, E., The ICONS Project Team and The ICONS Patient, Public and Carer Involvement Groups
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.

KeywordsCluster randomised controlled trial; Feasibility; Stroke; Urinary incontinence
Year2014
JournalTrials
Journal citation15 (509)
PublisherBioMed Central Ltd
ISSN1745-6215
Digital Object Identifier (DOI)doi:10.1186/1745-6215-15-509
Official URLhttps://doi.org/10.1186/1745-6215-15-509
Publication dates
Print23 Dec 2014
Publication process dates
Accepted09 Dec 2014
Deposited15 Jun 2020
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