Identifying Continence OptioNs after Stroke
| ISRCTN | ISRCTN08609907 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08609907 |
| Protocol serial number | 6659 |
| Sponsor | Lancashire Teaching Hospitals NHS Trust (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) |
- 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
Scientific
Room 434, Brook Building
University of Central Lancashire
Preston
PR1 2HE
United Kingdom
| lhthomas@uclan.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised interventional diagnosis, process of care and treatment trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Presence/absence of incontinence at six weeks post-stroke |
| Key secondary outcome measure(s) |
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. |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Room 434, Brook Building
Preston
PR1 2HE
United Kingdom
PR1 2HE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | feasibility trial results | 23/12/2014 | Yes | No | |
| Results article | results | 21/08/2015 | Yes | No | |
| Protocol article | protocol | 20/05/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/12/2017: internal review.
