Adults with stroke and urinary incontinence Nervous System Diseases Stroke and urinary incontinence
Conditions
Interventions
Participants who fulfil the eligibility criteria and have consented and completed their baseline questionnaire are randomised to either the intervention group or usual care group. Randomisation (1:1
moderate: 6-12
severe or very severe: 13-21
catheterised) using blocks of random length. The random allocation procedure is delivered using the secure remote web-based system provided by the Lancashire Clinical Trials Unit.
INT
a bladder scan to estimate post-void residual urine volume
and identification of the type of incontinence (stress UI: any response other than ‘never’ to the Leicester Urinary Symptom Questionnaire (LUSQ) question “Do you ever leak when you do any of the foll
urge UI: the response ‘most of the time’, ‘sometimes’ or ‘occasionally’ to the LUSQ question “When you get the urge to pass urine, does any leak before you get to the toilet?”
mixed UI: both stress and urge UI
‘functional’ UI, defined as mobility or balance restrictions stopping patients reaching the toilet on time).
The inte
Sponsors
University of Central Lancashire
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients aged 18 and older with: 1.1. Acute stroke 1.2. UI (at least one episode within a 24 hour period) OR an indwelling urethral catheter 1.3. NIH Stroke Scale level of consciousness 0-2
Exclusion criteria
Exclusion criteria: 1. Long-term indwelling urethral catheter pre-stroke 2. Subdural or subarachnoid haemorrhage
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of incontinence is measured using the International Consultation on Incontinence Questionnaire–Urinary Incontinence-Short Form (ICIQ-UI-SF ) total score at baseline, discharge from the stroke unit, 3 months (primary endpoint) and 6 months post-randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of days with indwelling urethral catheter in situ measured using patient notes at discharge from the stroke unit, and patient/consultee report at 3 and 6 months post-randomisation 2. Number of urinary tract infections measured using patient notes at discharge from the stroke unit, and patient/consultee report at 3 and 6 months 3. Urinary symptoms measured using the Leicester Urinary Symptom Questionnaire (LUSQ), questions “Do you ever leak when you do any of the following?” and “When you get the urge to pass urine, does any leak before you get to the toilet?” only) at baseline, 3 and 6 months 4. Functional ability measured using the Barthel Index at baseline, 3 and 6 months 5. Quality of life measured using the EuroQol (EQ-5D-5L) at baseline, 3 and 6 months 6. Incontinence-specific quality of life measured using the Incontinence Quality of Life Instrument (IQoL) at 3 and 6 months 7. Falls measured using adverse event reports at discharge from the stroke unit, and patient/consultee report at 3 and 6 months 8. Death measured using adverse event reports at discharge from the stroke unit, and by General Practitioner notification at 3 and 6 months | — |
Countries
England, United Kingdom
Outcome results
None listed