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Identifying continence options after stroke (ICONS): a cluster randomised controlled feasibility trial
Lois H Thomas1, Caroline L Watkins, Christopher J Sutton
1School of Health, University of Central Lancashire, Victoria Street, Preston PR1 2HE, UK. lhthomas@uclan.ac.uk.
Trials
|December 26, 2014
Summary
A feasibility trial of a systematic voiding programme (SVP) for urinary incontinence (UI) post-stroke met recruitment and retention goals. While not powered for effectiveness, some evidence suggests SVP may reduce urge incontinence. A full trial is recommended.
Area of Science:
- Stroke Rehabilitation
- Urology
- Geriatric Medicine
Background:
- Urinary incontinence (UI) is prevalent in post-stroke patients, often inadequately managed.
- Previous reviews show conservative interventions like bladder training benefit UI, but evidence in stroke survivors is limited.
Purpose of the Study:
- To assess the feasibility of a cluster randomized controlled trial for a systematic voiding programme (SVP) in managing post-stroke UI.
- To evaluate the effectiveness of SVP and SVP with supported implementation (SVP+) compared to usual care (UC) on UI and related outcomes.
Main Methods:
- A cluster randomized controlled feasibility trial involving 4 stroke services in each of three arms: SVP, SVP+, and UC.
- Feasibility outcomes included participant recruitment and retention rates.
- Effectiveness outcomes measured UI presence/absence at 6 and 12 weeks, UI type, continence at discharge, UI severity, function, quality of life, and mortality.
Main Results:
- Recruitment of 413 patients was successful, with acceptable retention rates (85% at 6 weeks, 88% at 12 weeks).
- No significant difference in the primary outcome of UI was observed between SVP/SVP+ and UC at 6 or 12 weeks.
- A potential reduction in urge incontinence was noted at 12 weeks in the intervention arms compared to usual care.
Conclusions:
- The systematic voiding programme (SVP) trial met its feasibility objectives for recruitment and retention.
- While not powered to confirm effectiveness, preliminary findings suggest a possible benefit for urge incontinence, warranting further investigation.
- A full-scale trial to definitively assess the effectiveness of SVP for post-stroke UI is recommended.
