Identifying Continence OptioNs after Stroke

ISRCTN	ISRCTN08609907
DOI	https://doi.org/10.1186/ISRCTN08609907
Secondary identifying numbers	6659

Submission date: 07/07/2010
Registration date: 07/07/2010
Last edited: 05/12/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Lois Thomas
Scientific

Room 434, Brook Building
University of Central Lancashire
Preston
PR1 2HE
United Kingdom

Email	lhthomas@uclan.ac.uk

Study information

Study design	Multicentre randomised interventional diagnosis, process of care and treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Management of urinary incontinence for patients recovering from stroke: a multicentre randomised interventional trial
Study acronym	ICONS
Study objectives	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(s)	Bradford Research Ethics Committee pending approval as of 20th July 2010 (ref: 10/H1302/60)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/2010
Completion date	30/06/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 796; UK sample size: 796
Key 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
Key exclusion criteria	Patients who refuse consent
Date of first enrolment	01/01/2010
Date of final enrolment	30/06/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Room 434, Brook Building

Preston
PR1 2HE
United Kingdom

Sponsor information

Lancashire Teaching Hospitals NHS Trust (UK)
Hospital/treatment centre

Royal Preston Hospital
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
England
United Kingdom

Email	douglas.mitchell@lthtr.nhs.uk
Website	http://www.lancsteachinghospitals.nhs.uk/
"ROR"	https://ror.org/02j7n9748

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	20/05/2011	Yes	No
Results article	feasibility trial results	23/12/2014	Yes	No
Results article	results	21/08/2015	Yes	No

Editorial Notes

05/12/2017: internal review.