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ISRCTN
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ISRCTN08609907
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ClinicalTrials.gov identifier
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Public title
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Identifying Continence OptioNs after Stroke
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Scientific title
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Management of urinary incontinence for patients recovering from stroke: a multicentre randomised interventional trial
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Acronym
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ICONS
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Serial number at source
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6659
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Study hypothesis
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Urinary incontinence is common after stroke and can be very unpleasant and a cause of distress and embarrassment for patients and their carers. Urinary incontinence may hamper rehabilitation and may affect whether or not patients are able to return to their own home, as well as return to leisure activities, work or an active social life. It is also costly for families and for the Health Service. We would like to try out a package of assessment and treatment of urinary incontinence while people are in hospital, which is designed to help them become continent again.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Bradford Research Ethics Committee pending approval as of 20th July 2010 (ref: 10/H1302/60)
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Study design
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Multicentre randomised interventional diagnosis, process of care and treatment trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Stroke Research Network; Subtopic: Rehabilitation; Disease: Therapy type, In hospital study
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Participants - inclusion criteria
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1. Aged 18 or over, either sex
2. Diagnosis of stroke based on the World Health Organization (WHO) criteria
3. Urinary incontinence (UI) as defined by the International Continence Society as "involuntary loss of urine"
4. Incontinence classified as stress UI, urge UI, mixed UI or 'functional' UI OR to be catheterised in the acute phase
5. Conscious (defined as either 'alert' or 'drowsy' on the Clinical Status on Admission Item of the European Stroke Database)
6. Medically stable as judged by the clinical team
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Participants - exclusion criteria
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Patients who refuse consent
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Anticipated start date
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01/01/2010
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Anticipated end date
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30/06/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Planned sample size: 796; UK sample size: 796
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Interventions
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1. Systematic voiding programme (intervention group I):
This group will receive the individualised systematic voiding programme tailored to the physical and cognitive capabilities of each patient. The programme has two routes:
1.1. A combined package including bladder training and pelvic floor muscle training for those patients who are cognitively able
1.2. Prompted voiding for those with cognitive impairment
2. Systematic voiding programme PLUS supported implementation (intervention group II):
This group will receive the intervention outlined above, together with supported implementation. This will comprise:
2.1. Identification of barriers and facilitators to the intervention
2.2. Targeted organisational development activities
2.3. Use of facilitation as a means of supporting change
3. Usual care (control group):
Participants in this group will receive usual care provided by the stroke service. This may comprise:
3.1. Checking for urinary tract infection
3.2. Checking for overflow incontinence (bladder scanners will be provided)
3.3. Containment using a variety of devices (for example absorbent products) with regular changes and some form of toileting schedule
Total duration of treatment: participants will receive the interventions for the duration of their stay in the acute/rehabilitation stroke units. The intervention phase of the trial will last for nine months.
Total duration of follow up: 12 months post-stroke
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Primary outcome measure(s)
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Presence/absence of incontinence at six weeks post-stroke
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Secondary outcome measure(s)
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Quality of life: Incontinence Quality of Life Instrument (I-QOL), measured at 6 weeks, 3 months and (for participants recruited in the first three months only) 12 months.
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Sources of funding
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National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR)
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Trial website
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Publications
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1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21599945
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Contact name
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Dr
Lois
Thomas
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Address
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Room 434, Brook Building
University of Central Lancashire
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City/town
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Preston
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Zip/Postcode
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PR1 2HE
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Country
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United Kingdom
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Email
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lhthomas@uclan.ac.uk
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Sponsor
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Lancashire Teaching Hospitals NHS Trust (UK)
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Address
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Royal Preston Hospital
Sharoe Green Lane
Fulwood
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City/town
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Preston
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Zip/Postcode
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PR2 9HT
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Country
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United Kingdom
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Email
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douglas.mitchell@lthtr.nhs.uk
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Sponsor website:
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http://www.lancsteachinghospitals.nhs.uk/
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Date applied
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07/07/2010
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Last edited
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11/01/2012
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Date ISRCTN assigned
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07/07/2010
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