Condition category
Circulatory System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Lois Thomas


Contact details

Room 434
Brook Building
University of Central Lancashire
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Management of urinary incontinence for patients recovering from stroke: a multicentre randomised interventional trial



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: Stroke Research Network; Subtopic: Rehabilitation; Disease: Therapy type, In hospital study


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



Phase I/II

Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants

Planned sample size: 796; UK sample size: 796

Participant exclusion criteria

Patients who refuse consent

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Room 434, Brook Building
United Kingdom

Sponsor information


Lancashire Teaching Hospitals NHS Trust (UK)

Sponsor details

Royal Preston Hospital
Sharoe Green Lane
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

2011 protocol in:
2014 feasibility trial results in:
2015 results in:

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

05/12/2017: internal review.