The Catheter Trial
Types of urethral catheter for reducing symptomatic urinary tract infections hospitalised adults requiring short-term catheterisation: multicentre randomised controlled trial of antibiotic and antiseptic impregnated urethral catheters (The Catheter Trial)
25% of patients admitted to hospital will require urethral catheterisation at some stage during their stay, and the risk of developing bacteriuria in catheterised patients is approximately 5% per day. 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 (CASUTI) 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. Consequently, any intervention that reduces the incidence of CASUTI may have wide-ranging repercussions.
A wide variety of preventive measures have been investigated, including meatal care measures, pre-connected catheter-collection systems, antiseptic drainage bags, routine bladder irrigation, and prophylactic antibiotics, but the evidence in support of these measures is weak at best. However, coating of urinary catheters with antibiotic or antiseptic compounds is thought to be a potentially effective preventative measure.
A recent Cochrane review of randomised controlled trials concluded that the silver alloy impregnated catheter (an antiseptic impregnated catheter) has the most evidence of benefit out of the antibiotic / antiseptic impregnated urethral catheters available. However, the included trials were small and of poor or moderate quality. A reduction in risk of catheter-associated urinary tract infections by up to 40% was reported in hospitalised adults having a short-term catheter. The evidence for antibiotic impregnated urethral catheters was relatively weak, with only one type of catheter (i.e. minocycline and rifampicin impregnated catheter) from one trial being considered in the review. However, minocycline and rifampicin impregnated catheters are no longer available (oral communication with Cook Urological, 03/10/05). Another recent small trial investigating a different type of antibiotic impregnated catheter (nitrofurazone impregnated urethral catheter, marketed by Rochester Medical) revealed no evidence of a difference in the incidence of bacteriuria between the nitrofurazone impregnated and standard silicone catheters in patients catheterised for up to 1 week.
In summary, the majority of clinical trials conducted thus far have been small and of poor to moderate quality in terms of trial methodology and design, outcome measures (such as reporting of bacteriuria rather than symptomatic urinary tract infection) and the lack of a comprehensive evaluation.
How will the results of this trial be used?
The trial results will have implications for the management of patients requiring short-term urethral catheterisation in hospital and rationalise catheter purchasing policies for large organisations like the NHS. If the use of an antibiotic or antiseptic impregnated urethral catheter leads to a significant reduction in CASUTI compared with a standard catheter and proves to be cost-effective, it will inform future short-term catheter policies in secondary care in addition to identification of at risk sub groups where the use of more expensive catheters might be particularly cost-effective. The trial will clarify amongst currently available catheters which should be used in the NHS.
Source of funding for study
The study is funded by the UK NHS Health Technology Assessment Programme.
Participating centres
The following centres were involved in the recruitment of participants for the trial:
- Aberdeen Royal Infirmary
- Raigmore Hospital Inverness
- Newcastle General Hospital
- Hillingdon Hospital
- Western General Hospital/Edinburgh Royal Infirmary
- Sunderland Royal Hospital
- Southampton General Hospital
- North Tyneside General Hospital
- Guys & St Thomas Hospital
- Blackpool Victoria Hospital
- Royal Preston Hospital
- Nottingham University Hospitals
- Hinchingbrooke Hospital
- Yeovil Hospital
- Norfolk and Norwich University Hospital
- Royal Victoria Infirmary, Newcastle
- Torbay Hospital
- Liverpool Women's Hospital
- Royal Blackburn Hospital
- Newcastle Freeman Hospital
- Harrogate District Hospital
- Queen Alexandra Hospital, Portsmouth
- Burnley General Hospital
For more information regarding The Catheter Trial please contact Kath Starr on 01224 438120 or email: k.starr@abdn.ac.uk
Please follow this link to the trial website:-