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

Lois H. Thomas*, Caroline L. Watkins, Christopher J. Sutton, Denise Forshaw, Michael J. Leathley, Beverley French, Christopher R. Burton, Francine Cheater, Brenda Roe, David Britt, Joanne Booth, Elaine McColl, Michael Leathley, Bernadette Carter, Jo Booth, Christopher Burton, Helen Rodgers, Katie Brittain, Andrew Walker, James BarrettGemma Whiteley, Pat Brand, May Griffiths, Philip Helvin, Brian James, Gill Pearl, Jane Whitewood, Jacqui Vella, Richard Childs, Sean Crosby, Steve Hall, Anj Lewin, Liz Royle, Carole Scott, Jean Wright, ICONS Project Team, ICONS Patient, Public and Carer Involvement Groups

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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). 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). 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
Article number509
JournalTrials
Volume15
Issue number1
DOIs
Publication statusPublished - 23 Dec 2014

Keywords

  • Cluster randomised controlled trial
  • Feasibility
  • Stroke
  • Urinary incontinence

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