Details of HTA project in progress
Last updated: 31 August 2010 - Next update due: 7 September 2010
Research type: |
Primary Research (e.g. trial) |
Project title: |
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 |
Project ref: |
05/46/01 |
Cost: |
£1,582,036 |
Chief Investigator : |
Professor James Michael Olu N'Dow, Professor of Urology, Academic Urology Unit, University of Aberdeen |
Project Website |
http://www.charttrials.abdn.ac.uk/catheter |
Start Date: |
February 2007 |
Estimated date of publication in HTA journal series: |
Late 2012. This date takes account of time for report preparation and printing based on current average times for these activities. |
Plain English Summary |
About 1 in 4 patients in hospital need a urinary catheter for a short while. This may cause a urine infection in about 7% of them, amounting to about 30,000 patients per year in the UK. These infections are important because they slow patients' recovery from illness or surgery and can lead to serious consequences such as bloodstream infections. The 15% reduction in such infections called for in the NHS Plan is hard to achieve as, unfortunately, the catheters always become contaminated with bacteria from the patient's own skin or bowel. For every day that the catheter is left in, bacteria colonise the urine in about 5% of patients. Simple measures such as general hygiene and taking the catheters out as soon as possible help to reduce the overall risk of developing a urine infection. Recently it has been shown that catheters containing antibiotics or antiseptics such as silver reduce colonisation by bacteria and may lessen the risk of infection. But these catheters are expensive and it is not clear how much they benefit individual patients and whether the increased costs are matched by better health. We plan to compare the use of standard catheters with those containing antibiotics or antiseptics in patients who only need a catheter for a short time (less than 2 weeks). Several large hospitals are involved which provide acute medical and surgical care. Patients who need a catheter as part of their routine care will be randomly allocated to have either a standard or a treated catheter. They will be asked to fill in questionnaires in hospital and after they go home to find out whether a urine infection occurred and if this affected their health, treatment or hospital stay. The costs and benefits of each type of catheter can then be compared to see whether one is better than another for routine use in the NHS. We will also study sub-groups of patients vulnerable to severe infection, such as the elderly and those in intensive care, to see whether treated catheters might particularly benefit them. To answer these questions quickly and with certainty a large trial involving multiple centres is required. To ensure success we have assembled a team of clinicians, researchers and economists who have wide previous experience in this area. The costs of the trial are justified by the number of patients likely to benefit and savings to the NHS. The results of the study will allow the NHS to decide whether, for short term use, catheters containing antibiotics or antiseptics rather than standard catheters reduce infections, result in better patient health and are cost-effective. |
Project Abstract: |
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. |
NRR* number, if applicable: |
N0484190625 (*National Research Register). The National Research Register was a public database of ongoing and recently completed research projects funded by, or of interest to, the United Kingdom's National Health Service (NHS). It is now an archive of projects from early 2000 to September 2007. Search the NRR archive. |
ISRCTN* number: | ISRCTN 75198618 (*International Standard Randomised Controlled Trial Number) URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN75198618 |
Project Protocol: |
Project protocol (pdf format, 193 kbytes) |
URL of this page: |
http://www.hta.ac.uk/1536 |
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