It has been estimated that symptomatic urinary tract infection occurs in approximately 20% of patients with bacteriuria, the presence of bacteria in urine, whilst bacteraemia, the presence of bacteria in the blood, occurs in up to 4% of these patients. Catheter-associated symptomatic urinary tract infections are the leading cause of hospital acquired infections, accounting for between 23% and 40% of all cases, and such infections result in additional morbidity and mortality and represent a considerable economic burden to the health care sector, patients and their carers.
What is the clinical benefit and cost-effectiveness of using antibiotic- (nitrofurazone) or antiseptic-impregnated (silver-alloy) urethral catheters over standard urethral catheters in hospitalised adults requiring short-term catheterisation?
The hypothesis being tested is that use of either of the impregnated catheters will reduce the incidence of catheter associated symptomatic urinary tract infection by 40% relative to the standard PTFE coated latex catheter (an absolute reduction of around 3%).
Randomised controlled trial testing three short-term urinary catheter policies in a range of high-volume clinical settings. 8 centres, involving over 5000 patients catheterised for up to 14 days.
Two experimental groups:
a) silver alloy impregnated hydrogel urethral catheter.
b) nitrofurazone impregnated silicone urethral catheter.
Control group: PTFE coated latex urethral catheter - the �standard' control.
Primary clinical outcome measure
Incidence of symptomatic urinary tract infection up to 6 weeks post catheter insertion (number of participants with at least one occurrence).
Secondary clinical outcome measures
Health related quality of life measured by EQ-5D at 6 weeks.
Other significant clinical events: septicaemia and mortality.
Adverse effects of catheterisation apart from symptomatic UTI (e.g. urethral discomfort and pain on removal).
Microbial aetiology of symptomatic UTI (i.e. types of bacteria and sensitivities).
Incidence of asymptomatic bacteriuria.
Antibiotic use following randomisation and indication.
Assessment of the risk of antimicrobial resistance towards silver and nitrofurazone using urine specimens from patients diagnosed with symptomatic UTI and bacteriuria.
Patient satisfaction with catheter (such as assessment of comfort).
Secondary economic outcome measures
Incremental cost per infection averted and QALYs gained.
Cost to the NHS and patient of the different catheters.