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

Lois H. Thomas, Beverley French, Christopher J. Sutton, Denise Forshaw, Micheal Leathley, Christopher R. Burton, Brenda Roe, Francine Cheater, Jo Booth, Elaine McColl, Bernadette Carter, Andrew Walker, Katie Brittain, Gemma Whitely, Helen Rodgers, James Barrett, Caroline Watkins

Research output: Book/ReportCommissioned report

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.
Original languageEnglish
Commissioning bodyNational Institute for Health Research
Number of pages600
Volume3
DOIs
Publication statusPublished - Mar 2015

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Secondary Care
Urinary Incontinence
Randomized Controlled Trials
Stroke
Confidence Intervals
Odds Ratio
Urge Urinary Incontinence
Wales
Activities of Daily Living
Workload
England
Cost-Benefit Analysis
Biomedical Research
Economics
Quality of Life
Outcome Assessment (Health Care)

Keywords

  • stroke
  • urinary incontinence
  • case study
  • ICONS
  • interventions
  • involvement

Cite this

Thomas, Lois H. ; French, Beverley ; Sutton, Christopher J. ; Forshaw, Denise ; Leathley, Micheal ; Burton, Christopher R. ; Roe, Brenda ; Cheater, Francine ; Booth, Jo ; McColl, Elaine ; Carter, Bernadette ; Walker, Andrew ; Brittain, Katie ; Whitely, Gemma ; Rodgers, Helen ; Barrett, James ; Watkins, Caroline. / 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. 2015. 600 p.
@book{5d03c8bfc721427caec0f473618f506d,
title = "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",
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.",
keywords = "stroke, urinary incontinence, case study, ICONS, interventions, involvement",
author = "Thomas, {Lois H.} and Beverley French and Sutton, {Christopher J.} and Denise Forshaw and Micheal Leathley and Burton, {Christopher R.} and Brenda Roe and Francine Cheater and Jo Booth and Elaine McColl and Bernadette Carter and Andrew Walker and Katie Brittain and Gemma Whitely and Helen Rodgers and James Barrett and Caroline Watkins",
year = "2015",
month = "3",
doi = "10.3310/pgfar03010",
language = "English",
volume = "3",

}

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 H.; French, Beverley; Sutton, Christopher J.; Forshaw, Denise; Leathley, Micheal; Burton, Christopher R.; Roe, Brenda; Cheater, Francine; Booth, Jo; McColl, Elaine; Carter, Bernadette; Walker, Andrew; Brittain, Katie; Whitely, Gemma; Rodgers, Helen; Barrett, James; Watkins, Caroline.

2015. 600 p.

Research output: Book/ReportCommissioned report

TY - BOOK

T1 - 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

AU - Thomas, Lois H.

AU - French, Beverley

AU - Sutton, Christopher J.

AU - Forshaw, Denise

AU - Leathley, Micheal

AU - Burton, Christopher R.

AU - Roe, Brenda

AU - Cheater, Francine

AU - Booth, Jo

AU - McColl, Elaine

AU - Carter, Bernadette

AU - Walker, Andrew

AU - Brittain, Katie

AU - Whitely, Gemma

AU - Rodgers, Helen

AU - Barrett, James

AU - Watkins, Caroline

PY - 2015/3

Y1 - 2015/3

N2 - 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.

AB - 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.

KW - stroke

KW - urinary incontinence

KW - case study

KW - ICONS

KW - interventions

KW - involvement

U2 - 10.3310/pgfar03010

DO - 10.3310/pgfar03010

M3 - Commissioned report

VL - 3

BT - 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

ER -