Condition category
Circulatory System
Date applied
07/07/2010
Date assigned
07/07/2010
Last edited
24/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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
-
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

http://www.lancsteachinghospitals.nhs.uk/

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 results in: http://www.ncbi.nlm.nih.gov/pubmed/25539714
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26293927

Publication citations

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes