Development and clinical trial of a mixed (multi/single-use)catheter management package for users of intermittent catheterisation

Summary:

In the UK about 50,000 people have bladder-emptying problems managed by IC. A Cochrane review found insufficient evidence to recommend any particular catheter for IC, yet the UK supplies most patients with single-use ones (which are expensive, £60 million pa) but worldwide multi-use catheters are typical. Reuse of catheters could benefit patients, and allow substantial NHS savings.

Evaluating the safety and acceptability of reusing catheters for intermittent catheterisation (IC - passing a tube into the bladder to drain urine) is one of the top 10 continence research priorities. UK practice is only to use single-use catheters but new draft NICE guidance recommends multi-use catheters whilst acknowledging the limited evidence for doing so. We need evidence that multi-use of catheters is at least as good as using only single-use catheters and a strong implementation plan, if we are to change practice, but currently we do not have a robust intervention or well-developed outcomes to measure infection, acceptability and preference in order to carry out a trial. This programme of work aims to prepare these and carry out a non-inferiority clinical trial comparing a multi/single-use ‘mixed package’ with use of only single-use catheters.

Outcomes/Impact: 

Implementation of a mixed IC package is likely to offer important benefits to patients by providing the advantages of multi-use (e.g. fewer packs to carry) and single-use (e.g. no added lubricant). Were around half of patients to change to a mixed package there would be NHS savings of more than £10 million pa.

If it can be shown that a mixed IC package is safe and acceptable widespread adoption will require major practice change. A robust knowledge transfer plan and framework for change will be needed which will be developed in the ‘implementation’ module.

Principal Investigator: University of Southampton

NMAHP Research Unit Collaborators: Professor Doreen McClurg

External Collaborators: Buckley B, Cottenden A - University College London, Cotterill N - Bristol Urological Institute, Malone-Lee J - Royal Free and University College Medical School, Gage H - University of Surrey, Moore M - Primary Care Research Network, Morris N - Bristol Urological Institute, Nicholls P - University of Southampton, Prieto J - University of Southampton, Shaw C - University of Glamorgan, Williams J - Southampton City PCT, Bowling A - University College London.

Funder:  Glasgow Children's Hospital Charity