1. ICONS III: Identifying Continence OptioNs after Stroke: developing a combined intervention for stroke survivors with urinary incontinence in the community

2. ICONS III team Chief Investigator: Professor Lois Thomas Co-applicants
1 Dr Jean Hay-Smith (New Zealand)
2 Professor Joanne Booth (Scotland)
3 Dr Sarah Dean (England
4 Dr Céu Mateus (England)
5 Dr Carol Bugge (Scotland)
6 Dr Rachel Stockley (England)
7 Jacqueline Coupe (England)
8 Lorna Booth (Scotland)
9 Mr Simon Hill (England)
10 Dr Miland Joshi (England)
11 Dr Joan Ostaszkiewicz (Australia)
12 Professor Suzanne Hagen (Scotland)
13 Dr Chantale Dumoulin (Canada)
14 Clare Bolton (England)
15 Professor Brenda Roe (England)
Our writing group brings together a new team of highly experienced, multi-disciplinary researchers from Universities and 4 countries to address an important, yet often ignored, global problem experienced by many people after stroke.
Our team has all the experience necessary to successfully bid for funding:
We have methodological experience in:
clinical trials
systematic review
theory-informed intervention development
process evaluation
Statistics
cost-effectiveness evaluation
We also have subject-specific expertise in:
Incontinence
Nursing
Physiotherapy
and medicine

3. Urinary incontinence after stroke is a global problem i)
Up to 8.45 million people affected worldwide annually
Feigin VL, Forouzanfar MH, Krishnamurthi R, Mensah GA, Connor M, Bennett DA, et al. Global and regional burden of stroke during : findings from the Global Burden of Disease Study Lancet. 2014;383(9913):

4. Urinary incontinence is a global problem ii)
Urinary incontinence affects half of stroke survivors in the acute phase
44% remain incontinent at 3 months
38% remain incontinence at 1 year
Current practice:
care focused on containment (e.g. absorbent pads) rather than promoting continence
overuse of indwelling urethral catheters – 45% of intervention participants in our ICONS feasibility trial
increased risk of IUC-associated urinary tract infections increased morbidity, mortality and resource use

5. ICONS II
Aim: to evaluate the clinical and economic effect of a systematic voiding programme for urinary incontinence (UI) after stroke in secondary care.
Systematic voiding programme comprises
comprehensive continence assessment
protocol for indwelling urethral catheter removal
behavioural interventions – bladder training or prompted voiding
Pragmatic, multicentre, randomised parallel group trial to compare the effectiveness of the systematic voiding programme (n=512) with usual care (n=512) in reducing the severity of UI in patients with stroke and UI in secondary care.
Behavioural interventions: a conservative approach that do not involve treatment with drugs or surgery (ICI 2016)
Results from an internal pilot with a target of 355 participants will determine progression to full trial.

6. ICONS III writing group aim
To be commissioned by NIHR to test a theory-informed combined intervention for patients with UI after stroke in the community

7. Working group plan Update two systematic reviews
Combined conservative interventions for urge, stress or mixed incontinence in adults
Qualitative narrative review of barriers and facilitators to behavioural interventions for urinary incontinence from the perspective of patients and clinical staff
Conduct a critical review of continence programmes for urinary incontinence
Develop a theory-informed intervention to treat both urge and stress urinary incontinence in stroke survivors in the community
Design a feasibility randomised controlled trial of the intervention
Develop a bid for submission to NIHR in April 2019
Our writing group will begin by updating two systematic reviews originally completed for our ICONS programme grant:
Combined conservative interventions for urge, stress or mixed incontinence in adults
Qualitative narrative review of barriers and facilitators to behavioural interventions for urinary incontinence from the perspective of patients and clinical staff
Based on these, the group will develop a theory-informed intervention designed to address both urge and stress urinary incontinence in patients with UI following stroke in the community.

8. Review 1) Update quantitative evidence for combined behavioural interventions for UI
Aim
Primary objective: to assess the effects of combined behavioural interventions for urge, stress, or mixed urinary incontinence in adults on the number of participants regaining continence and the number of incontinent episodes
Secondary objective: to assess the effects of combined behavioural interventions on physical measures of the severity of urinary incontinence, quality of life and adverse events
Design
Quantitative review with meta-analysis

9. Review 2) Update qualitative evidence of barriers and facilitators to successful implementation of behavioural interventions for UI
Aim
to evaluate factors influencing uptake and delivery of behavioural interventions for urinary incontinence from the perspective of clients and clinical staff
Design
Qualitative evidence synthesis

10. Review 3) Critical review of continence programmes
Aim
to produce a detailed descriptive account of behavioural interventions used in continence programmes for treating urinary incontinence in adults
using Michie et al.’s (2011) behaviour change wheel, to classify the intervention functions studies use (for example training), and which essential conditions of behaviour change (capability, opportunity and motivation) these address
Design
matrix analysis
identify which combinations of intervention components, participants, deliverer (e.g. patient, carer, clinical staff), delivery (e.g. intensity, duration), and context (e.g. setting, mode of delivery) appear to influence outcomes
This review aims to produce a detailed descriptive account of behavioural interventions used in continence programmes for treating urinary incontinence in adults. The lack of detailed description of interventions in published studies of complex interventions, including those for urinary incontinence, limits knowledge of the elements required for an effective intervention, hampering implementation and replication of findings. In addition, key components of interventions, the influence of context and the relationship to outcomes have not been described systematically.
Successful implementation of interventions, including continence programmes, requires behaviour change by patients, their carers and clinical staff. We will use Michie et al.’s (2011) behaviour change wheel to classify the intervention functions studies use (for example training), and which essential conditions of behaviour change (capability, opportunity and motivation) these address.
We have written the protocol for this review. The same search strategy underpins all three reviews: screening for all three reviews using the same search results will enable us to make quicker progress in identifying included studies for each review.

11. The intervention might comprise …
introduce pelvic floor muscle training (PFMT) at home alongside bladder training once patients are discharged, perhaps giving patients training while they are in hospital
continuing at home with bladder training only
use an app for PFMT – Eva Samuelsson has developed one, there is also the NHS Squeezy app

12. Thank you! Any questions?
+44(0)
Funding acknowledgement: ICONS II is funded by the NIHR HTA Programme (16/111/31). Department of Health disclaimer: The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health