ICONS II was a randomised controlled trial to compare the effectiveness and cost-effectiveness of a systematic voiding programme with usual care in reducing the severity of urinary incontinence in patients with stroke.
Further information about the project
ICONS II aimed to address the management of urinary incontinence (UI) in patients admitted to hospital with acute stroke. UI affects around half of stroke survivors in the acute phase. As many as 44% and 38% of stroke survivors remain incontinent at 3 months and 1 year respectively. Currently, patients with UI after stroke typically receive care focused on containment using strategies that do not promote continence (e.g. absorbent pads) and are likely to be harmful (e.g. indwelling urethral catheters).
ICONS II was a pragmatic, multicentre, individual patient randomised, two parallel group trial with an internal pilot and was informed by the ICONS-I feasibility trial. Participants were randomised to the intervention, a systematic voiding programme (SVP), or to usual care. The systematic voiding programme comprised assessment, behavioural interventions (bladder training or prompted voiding) and review. The assessment included evaluation of the need for and possible removal of an indwelling urinary catheter. The primary outcome measure was severity of urinary incontinence (measured using the International Consultation on Incontinence Questionnaire) at 3 months post randomisation. The planned sample size was 1024 participants, with 512 allocated to each of the intervention and the usual-care groups.