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

Thomas, Lois, French, Beverley, Sutton, Christopher, Forshaw, Denise, Leathley, Michael, Burton, Christopher R., Roe, Brenda, Cheater, Francine, Booth, Jo, McColl, Elaine, Carter, Bernadette, Walker, Andrew, Brittain, Katie, Whiteley, Gemma, Rodgers, Helen, Barrett, James and Watkins, Caroline (2015) 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. Programme Grants for Applied Research, 3 (1). pp. 1-602. ISSN 2050-4322

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Official URL: http://dx.doi.org/10.3310/pgfar03010

Abstract

Background

Urinary incontinence (UI) following acute stroke is common, affecting between 40% and 60% of people in hospital, but is often poorly managed.

Aim

To 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.

Design

Structured 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.

Setting

One English stroke service (case study) and 12 stroke services in England and Wales (randomised trial).

Participants

Case study, 43 patients; randomised trial, 413 patients admitted to hospital with stroke and UI.

Interventions

A 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 measures

Participant 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.

Results

There 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%.

Conclusions

The 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.

Item Type: Article
Additional Information: © Queen’s Printer and Controller of HMSO 2015. This work was produced by Thomas et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
Subjects: B900 Others in Subjects allied to Medicine
Department: Faculties > Health and Life Sciences > School of Health, Community and Education Studies > Nursing, Midwifery and Health
Depositing User: Ay Okpokam
Date Deposited: 07 Feb 2017 16:20
Last Modified: 07 Feb 2017 17:14
URI: http://nrl.northumbria.ac.uk/id/eprint/29551

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