Types of urethral catheter for reducing symptomatic urinary tract infections in hospitalised adults requiring short-term catheterisation: multicentre randomised controlled trial of antibiotic and antiseptic impregnated urethral catheters

Design: Eight-centre randomised controlled open trial testing three short-term urinary catheter policies in a range of high-volume clinical settings. Participants will be randomised centrally through the Aberdeen Centre for Healthcare Randomised Trials (CHaRT), stratified by centre and minimised by age, sex, and antibiotic use. Eight centres have agreed in principle to participate: Newcastle upon Tyne Hospitals NHS Trust, City Hospitals Sunderland NHS Foundation Trust, Gateshead Healthcare NHS Foundation Trust, Aberdeen Royal Infirmary NHS Grampian, Raigmore Hospital NHS Highland, Morriston Hospital, Swansea, Southampton University Hospitals, and Northumbria Healthcare. Setting: Secondary care units with a high volume of short-term catheterisation. In October 2005, an audit of catheter use in Newcastle and Aberdeen identified high volume units including: surgical specialities, general medical wards, care of the elderly wards, high dependency and intensive care units. Target Population: Adult patients (> 16 years of age) requiring urethral catheterisation for a maximum expected period of two weeks, in pre-selected units with a high volume of short-term catheterisation. Health Technologies Being Assessed: (1) Experimental Groups - There will be two experimental groups managed with: (i) silver alloy-impregnated hydrogel urethral catheter and (ii) nitrofurazone-impregnated urethral catheter (the only currently commercially available antibiotic-impregnated catheter). (2) Control Group - a PTFE-coated latex urethral catheter - the 'standard' control. The choice of catheter as 'standard' control was based on the results of the audit of short-term catheter use in all secondary care wards in Newcastle and Aberdeen, which confirmed that the PTFE-coated latex urethral catheter was the most commonly used in both hospitals (over 70%) and is relatively inexpensive. All catheters will be size 14 Ch. Measurement of Cost and Outcomes: Most outcomes will be measured at hospital discharge and in the community up to six weeks after randomisation. Primary outcome measures are: (i) clinical - incidence of symptomatic urinary tract infection up to six weeks after catheterisation [using the recently revised CDC definition based on microbiological examination of urine samples and pre-specified clinical symptoms and signs] and (ii) economic - cost-effectiveness measured in terms of incremental cost per symptomatic urinary tract infection avoided and incremental cost per QALY gained. Secondary outcomes are: (i) clinical - health related quality of life measured by SF36 and the EQ-5D, comfort and ease of use, incidence of bacteriuria and bacteraemia, bacterial resistance and other adverse effects including death; and (ii) economic - use of health care resources, cost to patients and their carers, costs to the NHS. The economic evaluation will include both a trial based analysis. Data on resource use in secondary and primary care will be collected. The perspective adopted for the analysis of incremental cost per symptomatic urinary tract infection avoided and incremental cost per QALY gained will be that of the NHS. Personal costs to the participants such as the purchase of medications will also be described to take into account the point of view of the patient. Key areas of uncertainty will be addressed using both probabilistic and deterministic (e.g. around unit costs or the implications of extrapolating outcomes beyond the trial) sensitivity analysis.