CATHETER II (Scotland)
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
254605
Contact name
Mohamed Abdel-fattah
Contact email
Sponsor organisation
Grampian Health Board
Duration of Study in the UK
4 years, 5 months, 31 days
Research summary
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.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.
REC name
Scotland A: Adults with Incapacity only
REC reference
19/SS/0012
Date of REC Opinion
28 Feb 2019
REC opinion
Unfavourable Opinion