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Open Access Study protocol

Study protocol: ICONS: Identifying continence options after stroke: A randomised trial

Lois H Thomas1*, Caroline L Watkins1, Beverley French1, Christopher Sutton1, Denise Forshaw1, Francine Cheater2, Brenda Roe3, Michael J Leathley1, Christopher Burton4, Elaine McColl5, Jo Booth6 and The ICONS Project Team and the ICONS Patient, Public and Carer Involvement Groups

Author Affiliations

1 School of Health, University of Central Lancashire, Preston, PR1 2HE, UK

2 Institute for Applied Health Research, Glasgow Caledonian University, Cowcaddens Road, Glasgow, G4 0BA, UK

3 Evidence-Based Practice Research Centre, Edge Hill University, St Helens Road, Ormskirk, L39 4QP, UK

4 Centre for Health-Related Research, Bangor University, Gwynedd, LL57 2EF, UK

5 Medical School, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK

6 School of Health, Glasgow Caledonian University, Cowcaddens Road, Glasgow, G4 0BA, UK

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Trials 2011, 12:131  doi:10.1186/1745-6215-12-131

Published: 20 May 2011

Abstract

Background

Urinary incontinence following acute stroke is common, affecting between 40%-60% of people in hospital after a stroke. Despite the availability of clinical guidelines for urinary incontinence and urinary incontinence after stroke, national audit data suggest incontinence is often poorly managed. Conservative interventions (e.g. bladder training, pelvic floor muscle training and prompted voiding) have been shown to have some effect with participants in Cochrane systematic reviews, but have not had their effectiveness demonstrated with stroke patients.

Methods/Design

A cluster randomised controlled pilot trial designed to assess the feasibility of a full-scale cluster randomised trial and to provide preliminary evidence of the effectiveness and cost-effectiveness of a systematic voiding programme for the management of continence after stroke. Stroke services will be randomised to receive the systematic voiding programme, the systematic voiding programme plus supported implementation, or usual care. The trial aims to recruit at least 780 participants in 12 stroke services (4 per arm). The primary outcome is presence/absence of incontinence at six weeks post-stroke. Secondary outcomes include frequency and severity of incontinence, quality of life and cost-utility. Outcomes will be measured at six weeks, three months and (for participants recruited in the first three months) twelve months after stroke. Process data will include rates of recruitment and retention and fidelity of intervention delivery. An integrated qualitative evaluation will be conducted in order to describe implementation and assist in explaining the potential mediators and modifiers of the process.

Trial Registration

ISRCTN: ISRCTN08609907