Title: Development of a mixed (reusable/disposable)catheter management package for users of intermittent catheterisation
Funder: Department of Health and Social Care

Abstract: Aims and objectives Establishing the safety, acceptability and costs of reusing catheters for intermittent catheterisation (IC - passing a tube into the bladder to drain urine) is a top continence research priority. We need to determine the best way to clean and reuse catheters (currently unknown), we need valid and reliable outcome measurement tools to measure the quality of life (QoL) of IC users and to measure symptomatic urinary tract infection (currently lacking), we need a clinical trial to compare use of reusable catheters (in a ‘mixed package’, combined with some disposables) with disposable catheters only and we need a robust knowledge transfer plan (should change be merited). Background In the UK about 50,000 people have bladder-emptying problems managed by IC. A recent Cochrane review found insufficient evidence to recommend any particular catheter for IC, yet the UK supplies most patients with disposable catheters (which are expensive, £60 million pa) although worldwide reusable ones are typical. Reusable catheters could benefit patients, and allow substantial savings to the NHS. Research Plans This programme consists of 5 modules; 4 concurrent (to develop the knowledge transfer plan, intervention and tools) which will prepare for and inform a 5th module (clinical trial). We will: Module 1A - map out the context and perspectives of UK IC practice using telephone interview (N=20) and internet survey (N=600) to inform a knowledge transfer plan. Module 1B - find the optimum methods to clean, store and lubricate catheters, with a user panel (N=10+10) Module 1C - develop and validate a questionnaire to measure catheter performance and QoL (N=55 +250). Module 1D - ask IC users (N=30) to monitor symptoms of infection for 6 months while having weekly laboratory analyses of urine to determine what symptoms are associated with UTI. Module 2 - carry out an RCT (N=103 per arm) comparing a mixed reusable/disposable IC package with use of disposable catheters . Research Team 3 leading continence research groups (Southampton, UCL and Bristol) with expertise in catheter-related infection and biofilms, QoL tool development, psychometrics, health services research, clinical trials, continence device development, technology transfer and implementation theory comprise the team. A health economist, statistician, CTU lead and recruitment lead are included. Key collaborators include user and professional continence organisations, clinical services, and international catheter experts. Programme Management This programme will be managed by MF (Professor of continence technology, Southampton) together with a programme manager. The four concurrent modules during the first two years will each have their own project teams (based in Southampton, UCL, Bristol) see Figure 1. Research Environment The research environments in the three centres have strong links to local clinical continence services, primary care research networks and have purpose-built laboratories for urinary catheter and biofilm work. Anticipated outputs Within a 5 year period: i) 1 or more, patient-friendly methods for cleaning, storing and lubricating reusable catheters ii) a valid and reliable QoL tool for IC users. iii) a validated IC symptom set for indicating symptomatic UTI. iv) evidence of the comparative acceptability, preference and effects on QoL, UTI and cost-effectiveness of a mixed reusable/disposable IC. v) a framework for implementing practice change (if merited). Outcomes and impact of this research on the health of patients and /or the public, and on the NHS Implementation of a mixed reusable/disposable IC package is likely to offer important benefits to patients by providing the advantages of reusability (less packs to carry, less waste) and disposability (no added lubricant, no cleaning/preparation of catheters). Widespread adoption of a mixed package will lead to substantial savings to the NHS. Dissemination of findings If it can be shown that reuse of catheters 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 Module 1A of the programme. Patients and Public involvement The Bladder and Bowel Foundation (BBF) have developed this programme with us and a trustee (ex-chair) is a co-applicant and will act as chair of the steering group. A representative user panel (N=10) have taken part in its development. Ethical implications This programme will require ethics and research governance approvals. Written consent , data protection and data storage processes will be followed based on standard procedures. The Clinical Trials Unit will oversee the trial. Justification for resources requested A full-time programme manager will manage the programme under MF. Module leaders, co-applicants, collaborators and user panelists have been costed plus research assistants and laboratory technicians.

Lay abstract: Establishing the safety and acceptability of reusing catheters for intermittent catheterisation (passing a small tube into the bladder to drain urine) is a top priority in the continence field. Globally both disposable and reusable catheters are used, but uniquely the UK supplies most patients with disposable catheters. Using reusable catheters together with disposable catheters (a ‘mixed’ IC package) could bring potential benefits to patients (more choice, practical, eco-friendly) and substantial savings to the NHS. Before promoting reusability we need to test whether catheter reuse is acceptable and safe for users in a clinical trial. The aim of this programme is to prepare for a trial by finding out which reusable methods (for cleaning, storing, lubricating) are best and develop ways to measure how IC affects people’s lives and how to detect urine infection accurately. We will then be able to test the safety and acceptability of a mixed package in a clinical trial. The objectives for each work module are to: 1. Identify and describe how and why different catheters are selected/prescribed from different viewpoints to inform future practice change (if merited) 2. Develop, test and compare methods of reusing, storing and lubricating catheters to identify the most effective, safe and practical techniques 3. Develop a questionnaire to measure quality of life of people using IC 4. Identify which symptoms relate to urine infection in IC users 5. Carry out a clinical trial to determine the acceptability of different catheter designs and the effect on quality of life and infection. At the end of the programme we plan to have: i) one or more evidence-based, patient-friendly methods for using reusable catheters, demonstrated in a booklet and on video; ii) a quality of life questionnaire for IC users for use in clinical practice and also for the clinical trial; iii) a symptom set for urine infections to help patients and clinicians better diagnose and treat urine infection and also for the clinical trial; iv) evidence of the comparative acceptability, effects on quality of life, urine infection and cost-effectiveness of a mixed reusable/disposable IC package to inform further research or implementation. A mixed IC package has the potential to provide more convenient and preferred options for some people; were around half of users to change to mixed methods there would be NHS savings of around £10 million per annum.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: GENERIC HEALTH RELEVANCE