Abstract
BACKGROUND AND OBJECTIVES: Much intermittent catheterisation (IC) is carried out using single-use catheters. Waste and costs could be reduced by cleaning and reusing catheters, but is it safe to do so? To answer these questions of safety and sustainability, clinical trials are needed. In this study, we developed a user-tested catheter cleaning method and training materials for use in a clinical trial. METHODS: Focus groups selected candidate cleaning methods and developed draft instructions. Users then home tested these methods on uncoated, plastic-based catheters, which were cleaned and reused up to 28 times. Reused and cleaned catheters were analysed using advanced microbiological analysis methods. The refined cleaning method was further tested by a naïve user panel. Additionally, a silicone catheter designed for reuse was tested in the laboratory and for user acceptability. User panel feedback was gathered throughout testing and thematically analysed. RESULTS: Twenty-six IC users were recruited to three user panels. Focus groups identified soap and water (SW) and soap and water plus a 15-minute soak in a chlorine-based cleaning solution (SW-Cl) as the preferred cleaning methods. User testing (≤3 reuses) and laboratory analysis showed SW alone to be less effective than SW-Cl: bacteria were detected in 23/120 (19%) male and 56/108 (52%) female SW samples versus 16/228 (7%) and 16/201 (8%) for SW-Cl. Bacteria were detected in only 1/240 (<0.5%) of catheter samples after 8-≥28 reuses with the SW-Cl method. Naïve user panel results were similar. The silicone catheter was acceptable to users and had comparable laboratory results using SW-Cl. User panel feedback informed refinement and simplification of the SW-Cl cleaning method and instructions. CONCLUSION: A chlorine-based method for cleaning catheters, which effectively removed bacteria from catheters reused multiple times, has been developed, tested and refined by users, and captured in an instruction booklet and video for inclusion in a clinical trial.