Thomas, L. H, Watkins, C. L, Sutton, C. J, Forshaw, D., Leathley, M. J, French, B., Burton, C. R, Cheater, F., Roe, B., Britt, D., Booth, J., McColl, E., Carter, B., Rodgers, H., Brittain, K., Walker, A., Barrett, J., Whiteley, G., Brand, P., Griffiths, M., Helvin, P., James, B., Pearl, G., Whitewood, J., Vella, J., Childs, A., Childs, R., Crosby, S., Hall, S., Lewin, A., Royle, L., Scott, C. & Wright, J. (2014). Identifying continence options after stroke (ICONS): A cluster randomised controlled feasibility trial. Trials,15(1), 1-15. United Kingdom: Biomed Central Ltd. Retrieved from https://doi.org/10.1186/1745-6215-15-509
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.
Open Access Journal Article