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

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. Trial registration: ISRCTN Registry, ISRCTN08609907, date of registration: 7 July 2010.

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