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

LH Thomas, CL Watkins, CJ Sutton, D Forshaw, MJ Leathley, B French, CR Burton, F Cheater, Brenda Roe, D Britt, J Booth, E McColl

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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.
    Original languageEnglish
    Pages (from-to)509
    JournalTrials
    Volume15
    Issue number1
    Early online date23 Dec 2014
    DOIs
    Publication statusPublished - 23 Dec 2014

    Keywords

    • Cluster randomised controlled trial
    • Feasibility
    • Stroke
    • Urinary incontinence
    • Humans
    • Wales
    • England
    • Male
    • Cognition
    • Urinary Incontinence/diagnosis
    • Cognitive Behavioral Therapy
    • Recovery of Function
    • Feasibility Studies
    • Patient Selection
    • Time Factors
    • Aged, 80 and over
    • Female
    • Odds Ratio
    • Stroke/complications
    • Treatment Outcome
    • Urinary Bladder/physiopathology
    • Urodynamics
    • Sample Size
    • Quality of Life
    • Aged

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