Randomised controlled trial comparing the clinical and cost-effectiveness of various washout policies versus no washout policy in preventing catheter-associated complications in adults living with long-term catheters

Plain English Summary

Background and study aims
Urinary catheters are soft tubes put into the bladder to drain and then collect urine. In the UK, an average of 1 in 1000 people use long-term indwelling catheters. People using these catheters can experience complications, like blockages (where the urine does not drain into the catheter bag properly), urinary infections, pain, and a type of incontinence called catheter bypass. These complications can affect a person’s quality of life. They may also mean more emergency visits with nurses and GPs. Research shows that people consider blockage to be one of the most troubling aspects of using catheters over a long period. In current standard catheter care, catheter blockages are dealt with by either changing the catheter more often and/or using catheter washout liquids to washout the catheter. Some people are advised to do a catheter washout every week to try to reduce blockages. Others are not. The difference is because at present, there is no clear evidence to show whether doing regular washouts helps avoid blockages. People doing washouts also use different solutions. One is a weak salty (saline) solution, and the other is a citric mix, more like weak lemon juice. Both solutions are used in the NHS but it is not known which works best. The aim of this study is to find out the best way to reduce the number of blockages that can happen in people who have long-term indwelling catheters to find out if washing out the catheter every week using catheter washout liquids reduces catheter blockages and other problems like urinary incontinence or urinary tract infections.

Who can participate?
Adult men and women who have been using a catheter for ≥ 28 days and for whom there is no plan for discontinuation of catheter use at the time of recruitment, who are able to or has someone who can do catheter washouts for them.

What does the study involve?
Participants are randomly allocated to one of three groups for 24 months:
1. Weekly normal saline catheter washouts plus standard care
2. Weekly acidic (citric) catheter washouts plus standard care
3. Standard care only (i.e. no catheter washouts)
Participants are given a special calendar to record any problems with their catheter. They are contacted each month by a member of the research team who asks about any catheter-related problems they may have had. Every six months, participants are asked to complete a questionnaire about their quality of life and satisfaction with treatment.

What are the possible benefits and risks of participating?
Participants will receive the same level of care from their healthcare team whether or not they take part in the study. Participants may not benefit personally from taking part, but will be directly helping us to improve the care of patients with a long-term catheter in the future.
The washout solutions used in the study are already being used in the NHS. There may be a possible increase in the risk of urine infection when doing regular catheter washouts. The researchers will monitor this closely within the study and will ask participants about urine infections during every follow-up in the study. There are some side effects from the long-term use of catheters but the researchers do not think that the risk will be increased by introducing regular washouts.

Where is the study run from?
University of Aberdeen (UK)

When is the study starting and how long is it expected to run for?
October 2019 to September 2023

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Dr Lynda Constable
l.constable@abdn.ac.uk

Study website

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• Scotland
• United Kingdom
• Wales

Study participating centres

Sponsor information

NHS Grampian
Hospital/treatment centre

-
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AB15 6RE
Scotland
United Kingdom

"ROR"	https://ror.org/00ma0mg56

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

08/04/2025: Publication reference added.
03/12/2024: Publication reference added.
25/10/2024: The participant level data sharing statement was added.
03/10/2024: The funder decided to stop the study early.
12/09/2024: The intention to publish date was changed from 31/03/2024 to 31/03/2025. IRAS number added.
11/10/2023: The following changes were made:
1. The overall study end date was changed from 29/02/2024 to 14/09/2023.
2. The total final enrolment was added.
08/08/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2023 to 31/08/2022.
2. The overall trial end date was changed from 31/03/2023 to 29/02/2024.
3. Manchester University Hospital NHS Foundation Trust, Solent NHS Trust, The White Horse Medical Practice, Mendip Vale Medical Practice (yatton), and Brierley Park Medical Centre were added as trial participating centres.
05/08/2022: Publication reference added.
22/04/2022: The following changes have been made:
1. The recruitment end date has been changed from 30/04/2022 to 31/03/2023.
2. The secondary outcome measures have been updated.
3. The participant exclusion criteria has been updated.
4. The trial participating centres “Derbyshire Community Health Services NHS Foundation Trust”, “Bicester Health Centre”, “Ashgate Medical Practice”, “Royal Primary Care Chesterfield”, “Royal Primary Care Clay Cross”, “Temple Sowerby Medical Practice”, “Humber Teaching NHS Foundation Trust”, “Aspatria Medical Group”, “Leadgate Surgery”, “Vauxhall Health Centre”, “Swanage Medical Practice”, “Chilwell Valley and Meadows Practice”, “Midlands Partnership NHS Foundation Trust”, “St Francis Surgery”, “Hockley Farm Medical Practice”, “Wellbrook Medical Cente”, “Banbury Cross Health Centre”, “Pelton & Fellrose Medical Group”, “The Shirley Health Partnership”, “Highcliffe Medical Centre”, “East Lancashire Hospitals NHS Trust”, “Church Street Practice”, “Derby Road Health Centre”, and “King’s College Hospital NHS Foundation Trust” have been added.
10/01/2022: The recruitment end date was changed from 31/12/2021 to 30/04/2022.
26/05/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/06/2021 to 31/12/2021.
2. The trial setting has been changed from Hospitals to Community.
3. The trial participating centres "Cambridge University Hospitals NHS Foundation Trust", "The Chalgrove & Watlington Surgeries", "Aneurin Bevan University Health Board", "St Bartholomew's Medical Centre", "Summertown Health Centre", "Priory Gardens Surgery", "Gosford Hill Medical Centre", and "Cwm Taf Morgannwg University Health Board" have been added.
04/09/2020: Recruitment to this study is no longer paused.
16/04/2020: Due to current public health guidance, recruitment for this study has been paused.
16/04/2020: NHS Lothian has been removed and Northumbria Healthcare NHS Foundation Trust, West Rainton Surgery, Great Lumley Surgery and The Haven Surgery have been added as trial participating centres.
04/11/2019: Trial's existence confirmed by the NIHR.