Types of urethral catheter for reducing symptomatic urinary tract infections in hospitalised adults requiring short-term catheterisation

Current primary outcome measures as of 15/05/2009:
Primary clinical outcome measure:
Incidence of symptomatic urinary tract infection at any time up to 6 weeks post randomisation (number of participants with at least one occurrence). This will be defined as any symptom reported at 3 days or 1 or 2 weeks post catheter removal or 6 weeks post-randomisation combined with a prescription of antibiotics, at any of these times, for presumed symptomatic UTI.

Subgroup analyses of the primary outcome will examine possible effect modification of age, gender, co-morbidity, duration of catheterisation, indication for catheterisation, and antibiotic use prior to enrolment.

Previous primary outcome measures:
Incidence of symptomatic urinary tract infection up to six weeks post catheter insertion (number of participants with at least one occurrence).

Secondary outcome measures as of 15/05/2009:

1. Secondary clinical outcome measures
1.1. Microbiological support of the primary outcome. Defined as those who fulfil the criteria for the primary outcome and in addition have any microbiologically positive result where there is >=10^4 CFU/mL of no more than two different species of uropathogen.

2. Secondary economic outcome measures
2.1. Incremental cost per infection averted and QALYs gained
2.2. Cost to the NHS and patient of the different catheters
2.3. Quality adjusted life-years (QALYs) estimated from EQ-5D responses

Tertiary outcome measures

3. Tertiary clinical outcomes
3.1. Early symptomatic urinary tract infection, defined as any self reported symptom with a prescription of antibiotics and a positive microbiological test (>=10^4 CFU/ml of no more than two different species of uropathogen) between randomisation and 3 days post catheter removal
3.2. Individually analyse the components of the definition of the primary and secondary outcome:
3.2.1. Any self-reported symptoms
3.2.2. Any antibiotic prescription for presumed symptomatic UTI.
3.2.3. Any microbiologically positive result (>=10^4 CFU/ml of no more than two different species of uropathogen)
3.3. Health related quality of life measured by the EQ-5D up to 6 weeks
3.4. Other significant clinical events: septicaemia and mortality
3.5. Adverse effects of catheterisation apart from symptomatic UTI (e.g. urethral discomfort and pain on removal)
3.6. Antibiotic use following randomisation and indication
3.7. Assessment of the risk of antimicrobial resistance towards silver and nitrofurazone using urine specimens from patients diagnosed with symptomatic UTI and bacteriuria

Previous secondary outcome measures:

Secondary clinical outcome measures:
1. Health related quality of life measured by Short Form Health Survey (SF-36) and the EuroQoL questionnaire (EQ-5D) at six weeks
2. Other significant clinical events: septicaemia and mortality
3. Adverse effects of catheterisation apart from symptomatic Urinary Tract Infection (UTI) (e.g. urethral discomfort and pain on removal)
4. Microbial aetiology of symptomatic UTI (i.e. types of bacteria and sensitivities)
5. Incidence of asymptomatic bacteriuria
6. Antibiotic use following randomisation and indication
7. Assessment of the risk of antimicrobial resistance towards silver and nitrofurazone using urine specimens from patients diagnosed with symptomatic UTI and bacteriuria
8. Patient satisfaction with catheter (such as assessment of comfort)

Secondary economic outcome measures:
1. Incremental cost per infection averted and Quality Adjusted Life Years (QALYs) gained
2. Cost to the NHS and patient of the different catheters
3. QALYs estimated from EQ-5D responses