Condition category
Nervous System Diseases
Date applied
15/02/2018
Date assigned
19/02/2018
Last edited
19/02/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Half of patients admitted to hospital with a stroke suffer from urinary incontinence (UI). As well as involuntary loss of urine, symptoms include an urgent desire to pass urine (urge incontinence) or leaking urine when laughing or sneezing (stress incontinence). These symptoms are more severe in stroke survivors than in other people with UI and affect patients’ ability to take part in rehabilitation and whether patients are able to return home. Many patients with stroke have urinary catheters inserted into the bladder to help with passing water. These are often not necessary and can lead to life-threatening infections.We have developed a programme for assessing and treating UI. It includes:
bladder training, which encourages people to extend the time between voids and helps them regain bladder control; prompted voiding, which aims to reduce incontinent episodes through verbal prompts to use the toilet and positive reinforcement from staff; a plan to remove urinary catheters if they are not necessary. The aim of this study is to assess whether the programme works in reducing the severity of UI and whether it should be recommended for use in routine clinical practice. There are four objectives. The first aim is to see if it is possible to recruit enough patients and if we can make sure patients in the “usual continence care” group do not receive the intervention. The second aim is to find out whether the programme reduces the severity of UI at 3 and 6 months after patients have been allocated to receive the intervention or care as usual. The third aim is to find out how the cost of providing the programme compares with providing care in the usual way, and whether it is economical to provide it given the benefits to patients and their families. Finally this study will assess how the programme is delivered, for example how well the programme instructions are followed.

Who can participate?
Adults aged 18 or over who have been admitted to hospital with stroke and have urinary incontinence or an indwelling urethral catheter.

What does the study involve?
Participants will receive either the programme for assessing and treating UI (described above) as well as usual continence care provided on the stroke unit, or usual continence care only.

What are the possible benefits and risks of participating?
We cannot guarantee any specific benefits for participants. Participants who receive the programme may find they have less sudden urges to go to the toilet, do not leak as often, or leak less urine. There are no serious side-effects associated with any part of this research.

Where is the study run from?
The study is being run by the University of Central Lancashire. There are 18 centres taking part.

When is the study starting and how long is it expected to run for?
November 2017 to October 2019

Who is funding the study?
National Institute for Health Research Health Technology Assessment Programme (UK)

Who is the main contact?
Dr Lois Thomas
lhthomas@uclan.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lois Thomas

ORCID ID

Contact details

Brook Building room 416
University of Central Lancashire
Preston
PR1 2HE
United Kingdom
+44 1772 893643
lhthomas@uclan.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NIHR HTA Programme trial reference: 16/111/31.

Study information

Scientific title

ICONS II: Identifying Continence OptioNs after Stroke randomised controlled trial

Acronym

ICONS II

Study hypothesis

Is a systematic voiding programme a clinically effective and cost effective treatment for urinary incontinence (UI) in patients with urinary incontinence after stroke in secondary care?

Ethics approval

Not provided at time of registration

Study design

Pragmatic multicentre randomised parallel group 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 contact details to request a participant information sheet.

Condition

Adults with stroke and urinary incontinence

Intervention

Participants who fulfil the eligibility criteria and have consented and completed their baseline questionnaire are randomised to either the intervention group or usual care group. Randomisation (1:1 ratio) is stratified by site and baseline continence category (none/slight: ICIQ-UI-SF score 0-5; moderate: 6-12; severe or very severe: 13-21; catheterised) using blocks of random length. The random allocation procedure is delivered using the secure remote web-based system provided by the Lancashire Clinical Trials Unit.

INTERVENTION:
The systematic voiding programme comprises assessment, behavioural interventions (bladder training or prompted voiding) and review. Assessment includes evaluation of the need for an IUC (to minimise inappropriate catheterisation), a protocol for IUC removal (if clinically justifiable), a 3 day bladder diary (to assess the pattern of UI) and an evidence-based continence assessment (to classify type of UI). The continence assessment includes: history taking, urine dipstick examination and (if indicated) a mid-stream urine specimen tested by microscopic examination, culture and sensitivities; a bladder scan to estimate post-void residual urine volume; and identification of the type of incontinence (stress UI: any response other than ‘never’ to the Leicester Urinary Symptom Questionnaire (LUSQ) question “Do you ever leak when you do any of the following?”; urge UI: the response ‘most of the time’, ‘sometimes’ or ‘occasionally’ to the LUSQ question “When you get the urge to pass urine, does any leak before you get to the toilet?”; mixed UI: both stress and urge UI; ‘functional’ UI, defined as mobility or balance restrictions stopping patients reaching the toilet on time).

The intervention begins within 24 hours of recruitment and continue until the patient is discharged from the stroke unit.

Participants who are catheterised are assessed for a trial without catheter. Participants who are not catheterised and are cognitively able receive bladder training; those with cognitive impairment OR patients with no control over their bladder receive prompted voiding. ICONS II staff make this decision (supported by the research nurse) based on the following criteria:

Prompted voiding: participants with cognitive impairment at baseline, defined as a score of 8 or more on the Six Item Cognitive Impairment Test (6-CIT (49)); or patients who have no control over their bladder, defined as answering ‘all the time’ to the ICIQ-UI-SF question ‘how often do you leak urine?’

Bladder training: participantss with no cognitive impairment at baseline, defined as a score of 0-7 on the 6-CIT, and some control over their bladder, defined as answering ‘several times a day’, ‘about once a day’, ‘two or three times a week’ or ‘about once a week or less often’ to the ICIQ-UI-SF question ‘how often do you leak urine?’

For participants catheterised in the acute stage, staff are asked to conduct a trial without catheter as early as possible unless there is a valid clinical reason not to do so, for example urinary retention, using a modified version of the HOUDINI protocol. Once the catheter is removed, participants begin assessment as described above.

USUAL CARE:
The standard patient care pathway often includes inserting an indwelling urethral catheter in the acute phase (139/289, 48% in the ICONS feasibility trial); there is typically no systematic approach to checking the need for continuing catheterisation or conducting a trial without catheter. The pathway may also include checking for urinary tract infection, containment using absorbent products and some form of toileting schedule for a small number of selected patients; this is unlikely to be based on a continence assessment or tailored to the patients’ continence pattern.

Referral for specialist assessment is recommended for persistent incontinence, but this is rarely done for stroke patients.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Severity of incontinence is measured using the International Consultation on Incontinence Questionnaire–Urinary Incontinence-Short Form (ICIQ-UI-SF ) total score at baseline, discharge from the stroke unit, 3 months (primary endpoint) and 6 months post-randomisation.

Secondary outcome measures

1. Number of days with indwelling urethral catheter in situ measured using patient notes at discharge from the stroke unit, and patient/consultee report at 3 and 6 months post-randomisation
2. Number of urinary tract infections measured using patient notes at discharge from the stroke unit, and patient/consultee report at 3 and 6 months
3. Urinary symptoms measured using the Leicester Urinary Symptom Questionnaire (LUSQ), questions “Do you ever leak when you do any of the following?” and “When you get the urge to pass urine, does any leak before you get to the toilet?” only) at baseline, 3 and 6 months
4. Functional ability measured using the Barthel Index at baseline, 3 and 6 months
5. Quality of life measured using the EuroQol (EQ-5D-5L) at baseline, 3 and 6 months
6. Incontinence-specific quality of life measured using the Incontinence Quality of Life Instrument (IQoL) at 3 and 6 months
7. Falls measured using adverse event reports at discharge from the stroke unit, and patient/consultee report at 3 and 6 months
8. Death measured using adverse event reports at discharge from the stroke unit, and by General Practitioner notification at 3 and 6 months

Overall trial start date

01/11/2017

Overall trial end date

30/11/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients aged 18 and older with:
1.1. Acute stroke
1.2. UI (at least one episode within a 24 hour period) OR an indwelling urethral catheter
1.3. NIH Stroke Scale level of consciousness 0-2

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

818 participants

Participant exclusion criteria

1. Long-term indwelling urethral catheter pre-stroke
2. Subdural or subarachnoid haemorrhage

Recruitment start date

01/05/2018

Recruitment end date

30/10/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Royal Bournmouth Hospital
Castle Lane East
Bournmouth
BH7 7DW
United Kingdom

Sponsor information

Organisation

University of Central Lancashire

Sponsor details

University of Central Lancashire
Lancashire Clinical Trials Unit
Preston
PR1 2HE
United Kingdom
+44 1772 893713
dforshaw@uclan.ac.uk

Sponsor type

University/education

Website

www.uclan.ac.uk

Funders

Funder type

Not defined

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

NIHR: Trial findings will be written up in the final report to the NIHR HTA Programme and published in the NIHR HTA Journal.

PATIENT PARTICIPANTS AND WIDER PATIENT, PUBLIC AND CARER NETWORKS: Findings will be disseminated to all patients and carers who participated in the research. Presentation of this information will be discussed with the ICONS II Patient, Carer and Public Involvement (PCPI) Groups and is likely to include a normal and an easy access summary.

The appropriate dissemination strategy for wider patient, public and carer networks will be informed by our ICONS II Patient, Public and Carer Groups. A summary of findings will be posted on the INVOLVE website (http://www.involve.org.uk/) and disseminated through the Patient, Carer and Public Involvement Leads in the 15 UK Clinical Networks. The PCPI strand of the trial will be submitted for publication in Health Expectations and members of the ICONS II PCPI Groups will present findings at a national conference (e.g. UK Stroke Forum) and local meetings.

CLINICAL STAFF: Findings will be disseminated to all clinical staff who participated in the research. Participants will be encouraged to cascade findings to the rest of the stroke service team through channels such as multidisciplinary team meetings and staff notice boards.

HEALTH COMMISSIONERS AND DECISION MAKERS: Findings will be shared through participating Trust, Clinical Research and Academic Health Science Networks across the UK. Findings will also be sent to relevant national UK organisations, e.g.: Governments and the NHS in England, Scotland, Wales and Northern Ireland; National Institute for Health and Care Excellence and Royal Colleges (e.g. Royal College of Nursing, Royal College of Physiotherapists). The summary will also be posted on the websites of the research team members’ organisations.

POLICY: Findings will be fed into the next update of the Intercollegiate Stroke Working Party National Clinical Guidelines and the NICE guideline on UI in neurological disease in order to facilitate wide access to health professionals.

ACADEMIC COMMUNITY: The trial findings and health economic evaluation papers will be submitted as a pair to a high impact journal, for example The Lancet or Stroke. Findings will also be submitted to profession-specific journals (e.g. Physiotherapy, Nursing Times) to maximise readership. Lead authors and timescales will be agreed by the Trial Management Group and will adhere to the ICMJE criteria for authorship http://www.icmje.org/.

Findings will be presented at a range of stroke, rehabilitation and incontinence related conferences, for example the European Stroke Conference, UK Stroke Forum, International Continence Society Conference and Association for Continence Advice Conference. Key findings will be shared on relevant social media, including blogs and twitter feeds (e.g. @UCLanHealth, @OfficialNIHR, @NIHRCRN).

KEY OUTPUTS
There will be three key outputs of this research
1. High quality evidence regarding the clinical effectiveness and cost-effectiveness of a systematic voiding programme to improve urinary incontinence after stroke. Such evidence does not currently exist in the UK and findings will enable commissioners and clinicians to make evidence-based decisions about adopting the intervention in similar NHS settings.
2. A multidisciplinary workforce with the knowledge and skills necessary to treat urinary incontinence after stroke in 18 stroke services. If the systematic voiding programme is shown to be effective, clinical staff who implemented the intervention will be encouraged to share experiences and practical suggestions for introducing the programme into practice in their units after the intervention period.
3. We will produce a comprehensive manual for implementing the programme should it prove effective and cost-effective. This will include relevant documentation as well as hints and tips for introducing, monitoring and evaluating the change in practice. The manual will be publicised as outlined in the dissemination strategy and will be available on the trial website. It will also include a link to the ICONS II online training.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/05/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes