The trial was stopped early in March 2020, at which point 157 participants had been randomised (intervention n = 79; usual care n = 78). There were major issues with attrition (potentially aggravated by COVID-19), with 45% of the primary outcome data missing: 56% of the intervention group data and 35% of the usual-care group data. It was also noted that the length of hospital stay in the ICONS-II trial was much shorter than that in the ICONS-I feasibility trial. The overall median length of stay (interquartile range) in the stroke unit was 27 (16–45) days in the ICONS-II trial and 47 (30–68) days in the ICONS-I feasibility trial which indicated that a purely hospital-based intervention would not provide a sufficient amount of the SVP to the patient to be effective in promoting continence.
In terms of the primary outcome, patients allocated to the intervention group had a lower score for severity of urinary incontinence (higher scores indicate greater severity in urinary incontinence) than those allocated to the usual-care group, with means (standard deviations) of 8.1 (7.4) and 9.1 (7.8), respectively, but this result should be interpreted with caution. With regard to secondary outcomes, the intervention group had lower estimated odds of a catheter being present at discharge than the usual-care group (odds ratio OR=0.55, 95% CI 0.27 to 1.12).
The trial had major issues with site and participant recruitment and retention, and difficulties delivering the intervention because of individual patient randomisation. These factors were aggravated by the ongoing COVID-19 situation and led to the decision to stop the trial early. Because of the small sample size, the results of this study should not be used to inform changes in clinical practice in the promotion of continence, but they may inform reduction in catheter use. The study findings suggest that, when designing a future trial, the intervention needs to be reviewed. The cause of incontinence should probably be diagnosed in hospital, and the intervention should probably be started in hospital and continue to be delivered in the community.
The trial report was published, the following is a reference and link to the publication:
Watkins C, Tishkovskaya S, Brown C, Sutton C, Sylvestre Garcia Y, Forshaw D, et al. Systematic voiding programme in adults with urinary incontinence following acute stroke: the ICONS-II RCT. Health Technology Assessment 2022; 26(31)
https://www.journalslibrary.nihr.ac.uk/hta/eftv1270/#/full-report
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.
Sponsorship
The study is sponsored by the University of Central Lancashire. It is being conducted with Lancashire Clinical Trials Unit, University of Central Lancashire.
Further information
To find out more about ICONS II, please contact the Chief Investigator, Professor Dame Caroline Watkins, clwatkins@uclan.ac.uk, 01772 893646 or the Principal Trial Manager, Mrs Denise Forshaw, dforshaw@uclan.ac.uk, 01772 893629.
