Identifying Continence OptioNs after Stroke (ICONS): an evidence synthesis, case study and exploratory cluster randomised controlled trial of the introduction of a systematic voiding programme for patients with urinary incontinence after stroke in secondary care

BackgroundUrinary incontinence (UI) following acute stroke is common, affecting between 40% and 60% of people in hospital, but is often poorly managed.AimTo develop, implement and evaluate the preliminary effectiveness and potential cost-effectiveness of a systematic voiding programme (SVP), with or without supported implementation, for the management of UI after stroke in secondary care.DesignStructured in line with the Medical Research Council framework for the evaluation of complex interventions, the programme comprised two phases: Phase I, evidence synthesis of combined approaches to manage UI post stroke, case study of the introduction of the SVP in one stroke service; Phase II, cluster randomised controlled exploratory trial incorporating a process evaluation and testing of health economic data collection methods.SettingOne English stroke service (case study) and 12 stroke services in England and Wales (randomised trial).ParticipantsCase study, 43 patients; randomised trial, 413 patients admitted to hospital with stroke and UI.InterventionsA SVP comprising assessment, individualised conservative interventions and weekly review. In the supported implementation trial arm, facilitation was used as an implementation strategy to support and enable people to change their practice.Main outcome measuresParticipant incontinence (presence/absence) at 12 weeks post stroke. Secondary outcomes were quality of life, frequency and severity of incontinence, urinary symptoms, activities of daily living and death, at discharge, 6, 12 and 52 weeks post stroke.ResultsThere was no suggestion of a beneficial effect on outcome at 12 weeks post stroke [intervention vs. usual care: odds ratio (OR) 1.02, 95% confidence interval (CI) 0.54 to 1.93; supported implementation vs. usual care: OR 1.06, 95% CI 0.54 to 2.09]. There was weak evidence of better outcomes on the Incontinence Impact Questionnaire in supported implementation (OR 1.22, 95% CI 0.72 to 2.08) but the CI is wide and includes both clinically relevant benefit and harm. Both intervention arms had a higher estimated odds of continence for patients with urge incontinence than usual care (intervention: OR 1.58, 95% CI 0.83 to 2.99; supported implementation: OR 1.73, 95% CI 0.88 to 3.43). The process evaluation showed that the SVP increased the visibility of continence management through greater evaluation of patients’ trajectories and outcomes, and closer attention to workload. In-hospital resource use had to be based on estimates provided by staff. The response rates for the postal questionnaires were 73% and 56% of eligible patients at 12 and 52 weeks respectively. Completion of individual data items varied between 67% and 100%.ConclusionsThe trial was exploratory and did not set out to establish effectiveness; however, there are indications the intervention may be effective in patients with urge and stress incontinence. A definitive trial is now warranted.Study registrationThis study is registered as ISRCTN08609907.Funding detailsThe National Institute for Health Research Programme Grants for Applied Research programme. Excess treatment costs and research support costs were funded by participating NHS trusts and health boards, Lancashire and Cumbria and East Anglia Comprehensive Local Research Networks and the Welsh National Institute for Social Care and Health Research.