Contact information
Type
Scientific
Primary contact
Dr Lois Thomas
ORCID ID
Contact details
Room 434
Brook Building
University of Central Lancashire
Preston
PR1 2HE
United Kingdom
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lhthomas@uclan.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6659
Study information
Scientific title
Management of urinary incontinence for patients recovering from stroke: a multicentre randomised interventional trial
Acronym
ICONS
Study hypothesis
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.
Ethics approval
Bradford Research Ethics Committee pending approval as of 20th July 2010 (ref: 10/H1302/60)
Study design
Multicentre randomised interventional diagnosis, process of care and treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Stroke Research Network; Subtopic: Rehabilitation; Disease: Therapy type, In hospital study
Intervention
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
Intervention type
Other
Phase
Phase I/II
Drug names
Primary outcome measures
Presence/absence of incontinence at six weeks post-stroke
Secondary outcome measures
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.
Overall trial start date
01/01/2010
Overall trial end date
30/06/2011
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 796; UK sample size: 796
Participant exclusion criteria
Patients who refuse consent
Recruitment start date
01/01/2010
Recruitment end date
30/06/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Room 434, Brook Building
Preston
PR1 2HE
United Kingdom
Sponsor information
Organisation
Lancashire Teaching Hospitals NHS Trust (UK)
Sponsor details
Royal Preston Hospital
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom
-
douglas.mitchell@lthtr.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21599945
2014 feasibility trial results in: http://www.ncbi.nlm.nih.gov/pubmed/25539714
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26293927
Publication citations
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Protocol
Thomas LH, Watkins CL, French B, Sutton C, Forshaw D, Cheater F, Roe B, Leathley MJ, Burton C, McColl E, Booth J, , , Study protocol: ICONS: identifying continence options after stroke: a randomised trial., Trials, 2011, 12, 131, doi: 10.1186/1745-6215-12-131.
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Results
Thomas LH, Watkins CL, Sutton CJ, Forshaw D, Leathley MJ, French B, Burton CR, Cheater F, Roe B, Britt D, Booth J, McColl E; ICONS Project Team and the ICONS Patient, Public and Carer Involvement Groups, Identifying continence options after stroke (ICONS): a cluster randomised controlled feasibility trial, Trials, 2014, 15, doi: 10.1186/1745-6215-15-509.
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Results
BMC Med Res Methodol, Assessing fidelity to treatment delivery in the ICONS (Identifying Continence OptioNs after Stroke) cluster randomised feasibility trial, BMC Med Res Methodol, 2015, 15, 1, 68, doi: 10.1186/s12874-015-0051-9.