Development of a mixed (reusable/disposable)catheter management package for users of intermittent catheterisation

Aims and objectivesEstablishing 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). BackgroundIn 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 PlansThis 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 Team3 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 ManagementThis 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 EnvironmentThe 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 outputsWithin a 5 year period: i) 1 or more, patient-friendly methods for cleaning, storing and lubricating reusable cathetersii) 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 NHSImplementation 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 findingsIf it can be shown that reuse of catheters is safe and acceptab