Title: ICONS II: Identifying Continence OptioNs after Stroke randomised controlled trial
Funder: Department of Health and Social Care

Abstract: DESIGN: randomised controlled trial and economic evaluation with internal pilot SETTING: 18 NHS stroke services with stroke units (19) TARGET POPULATION: adults with stroke and urinary incontinence (UI) or indwelling urethral catheter (IUC) INCLUSION CRITERIA - adults with acute stroke (20) - UI defined as “any involuntary loss of urine” (21) within 24 hours or presence of IUC at the time of consent - conscious: “Alert” or “Not alert but arousable” (NIHSS Point 1A score 0-1) on the NIH Stroke Scale (22, 23) within 72 hours of stroke onset EXCLUSION CRITERIA - long-term catheter pre-stroke HEALTH TECHNOLOGY: systematic voiding programme comprising assessment, behavioural interventions (bladder training or prompted voiding) and review. Assessment includes evaluation of the need for an IUC (to minimise inappropriate catheterisation), a protocol for IUC removal (if clinically justifiable (24)), a 3 day bladder diary (to assess the pattern of UI (25)) and an evidence-based continence assessment (to classify type of UI (3)). Patients who are cognitively able will receive bladder training which aims to promote continence (17); those with cognitive impairment will receive prompted voiding which aims to minimise UI episodes (26). Progress is reviewed weekly and the regime adjusted accordingly. MEASUREMENT OF COSTS AND OUTCOMES: the primary effectiveness outcome is severity of UI measured by the ICIQ-UI-SF (11) total score at baseline, 12 (primary endpoint) and 26 weeks post-randomisation. The ICIQ-UI-SF is reliable, valid and responsive (27). Those catheterised or dead will have the worst possible ICIQ-UI-SF score (21) imputed. Secondary effectiveness outcomes are quality of life (Incontinence Quality of Life Instrument (12, 13)) and the EQ-5D-5L (14)), urinary symptoms (Leicester Urinary Symptom Questionnaire (15)), activities of daily living (Barthel Index (16)), falls, and death at baseline, 12 and 26 weeks. Resource use data will be collected up to six months and will allow for the measurement of direct and indirect costs. SAMPLE SIZE: 12-week ICIQ-UI-SF total scores from 818 participants will provide at least 90% power to detect a 1.89 point between-arms difference (28) using an independent-samples t-test (alpha=5%), assuming no more than 25% of the true effect is lost due to contamination (based on a minimally important difference of 2.52 (28)) and a common SD of 8.32 (computed from data collected for the ICONS feasibility trial (4)). We will randomise 1024 participants to allow for 20% attrition (4, 5). TIMETABLE M-6--1 Ethics and R&D approvals; recruit sites M1-6 Pre-intervention training (2 months per site, 6 sites per wave) M3-18 Recruitment and intervention phase; 12 months per site, 5 patients per month per site M9-11 Internal pilot data analysis, reporting to TSC and IDMC M19-26 Collection of remaining outcome data M27-33 Data analysis, report writing and dissemination EXPERTISE IN TEAM Trial design and management, statistics, health economics, implementation, engagement with service users, clinical care and NHS management.

Lay abstract: Half of patients admitted to hospital with a stroke suffer from urinary incontinence (UI). As well as involuntary loss of urine, symptoms of UI include having an urgent desire to pass urine (urge incontinence) or leaking urine when laughing or sneezing (stress incontinence). These symptoms are more severe in stroke survivors than in other people with UI. They cause embarrassment and distress, and affect patients’ ability to take part in rehabilitation and whether patients are able to return home. Many patients with stroke have urinary catheters inserted into the bladder to help with passing water. These are often not necessary and can lead to life-threatening infections. We have developed a programme for assessing and treating UI in patients admitted to hospital with a stroke which could help them become continent. The programme includes: 1) bladder training, which encourages people to extend the time between voids and helps them regain bladder control; 2) prompted voiding, which aims to reduce incontinent episodes through verbal prompts to use the toilet and positive reinforcement from staff; 3) a plan to remove urinary catheters if they are not necessary. In our feasibility trial we tested whether it was possible to recruit and retain patients, how best to deliver the programme and whether the intervention was acceptable to patients and staff. We successfully introduced the programme in eight stroke services and recruited 413 patients. The programme and the trial methods were acceptable to patients and clinical teams. The feasibility trial was not designed to test if the programme worked, but found some evidence that patients with urge incontinence were less likely to have it at 12 weeks if they received the programme. Given these encouraging results, we would now like to assess whether the programme works in reducing UI and whether it should be recommended for use in routine clinical practice. We have four objectives. First, we will find out if it is possible to recruit enough patients and if we can make sure patients in the “usual continence care” group do not receive the intervention. We will assess these in months 3 to 8 and make a decision whether to continue the trial in month 10. Secondly, we will find out whether the programme reduces the severity of UI at 12 and 26 weeks after patients have consented to take part. We will do this by comparing patients who receive the programme to those who receive “usual continence care”. Thirdly, we will find out how the cost of providing the programme compares with providing care in the usual way, and whether it is economical to provide it given the benefits to patients and their families. Finally, we will assess how the programme is delivered, for example how well the programme instructions are followed. If the trial shows our programme does work, it is likely other stroke units will use it and many more patients and their families will benefit. This may also contribute to cost savings for the NHS, patients and families. We are confident we can successfully complete this research. Our team includes experienced researchers based at six Universities, including people from the main professions working with stroke patients (nurses, stroke physicians and urologists) as well as those with expertise in clinical trials, statistics, health economics and process evaluations. Our team includes two stroke survivors who have advised on the study design.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: RENAL AND UROGENITAL;STROKE