CATHETER II
Research type
Research Study
Full title
The CATHETER II Study: 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
IRAS ID
259559
Contact name
Mohamed Abdel-fattah
Contact email
Sponsor organisation
Grampian Health Board
ISRCTN Number
ISRCTN17116445
Duration of Study in the UK
4 years, 5 months, 31 days
Research summary
Summary of research:
In the UK, we estimate that, approximately, 1 in 500 people live with a long term catheter. A urinary catheter is a thin, soft, flexible tube inserted into the bladder to drain urine to a collection bag. LTCs can be associated with complications including catheter blockage and urinary tract infections. Catheter blockages affect 50% of people with LTCs. Blockage and infection can impact upon quality of life and NHS resources.There are two broad strategies for preventing and managing catheter blockage: more frequent change of catheter and/or the use of liquid solutions to washout or flush the catheters.
We do not know enough about the benefits, harms or costs of regular prophylactic washouts, to recommend whether or not they should be standard care.In this study we will determine the clinical and cost-effectiveness, acceptability, satisfaction, and safety of weekly prophylactic catheter washout policies in addition to standard LTC care compared to standard LTC care only for adults living with LTC.
The primary outcome is catheter blockage requiring intervention.
The primary economic outcome is the incremental cost per quality adjusted life year (QALY) gained for each washout policy compared to standard LTC care only.Summary of Research:
We are recruiting 600 people who have a LTC from primary care, secondary care and care homes. We are randomising participants to one of three groups.
• Saline washouts. A policy of weekly prophylactic normal saline catheter washouts plus standard LTC care.
• Acidic washouts. A policy of weekly prophylactic acidic (citric) catheter washouts plus standard LTC care.
• Standard LTC care only (i.e. no prophylactic catheter washouts).We are following participants for 24 months to assess catheter blockages, infections, and complications, plus their quality of life, satisfaction, costs to the participant and NHS. We are exploring the views, attitudes, experiences and expectations of washouts with participants, nurses, and doctors.
Summary of Findings:
Long-term catheters (LTC) are used by approximately 90,000 people in the UK for various reasons. Common problems when using the LTC are blockages of the catheter and urine infections which often require healthcare assistance and impact on quality of life. To help prevent these problems, current standard care involves changing the catheter every 12weeks or so. Some people also flush the catheter regularly with washout solutions, but there is no good evidence to support this. The CATHETER II study evaluated if flushing the catheter regularly reduces the number of blockages, urine infections and other catheter problems. It also asked participants if the washouts were acceptable to use and improved their quality of life.We recruited adults with LTC in the UK to take part. They were randomly allocated to (i)preventative washouts with saline, or (ii)preventative washouts with citric acid, or (iii)no preventative washouts. All participants continued standard LTC care. Participants, or their carer, were trained to do the washouts and these were administered every week for up to 24months. We contacted participants by telephone every month to ask about any problems with the catheter or washouts and asked them to complete a questionnaire about their quality of life every 6months. We interviewed participants and healthcare professionals to better understand their experience in the study.
The study ended early because it was difficult to recruit participants during the COVID-19 pandemic, with 80 of the planned 600 participants recruited. Therefore, the results are not conclusive but do suggest that regular preventative washouts might reduce the number of blockages of the catheter and urine infections. Participants and healthcare professionals who were interviewed said that people with LTC can be trained to do the washouts effectively. Participants had a generally positive experience using the washouts. Further studies will be needed.
REC name
Wales REC 6
REC reference
19/WA/0015
Date of REC Opinion
25 Feb 2019
REC opinion
Further Information Favourable Opinion