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

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

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 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2014;383(9913):245-54.

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

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.

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

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.

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

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

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.

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 https://www.bladderandbowel.org/news/squeezy-the-nhs-physiotherapy-app-for-pelvic-floor-muscle-exercises/  

Thank you! Any questions? lhthomas@uclan.ac.uk +44(0)1772 893643 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