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

Types of urethral catheter for reducing symptomatic urinary tract infections in hospitalised adults requiring short-term catheterisation: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN75198618

Enrollment

5700

Registered

2007-01-26

Start date

2007-02-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary tract infections Urological and Genital Diseases Urinary tract infections

Interventions

Three-arm randomised controlled trial testing three short-term urinary catheter policies in a range of high-volume clinical settings. Participants are randomised at each ward within each centre minim

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients (both males and females, more than or equal to 16 years of age) 2. Requiring urethral catheterisation (expected to be required for a maximum of two weeks) 3. Pre-selected units with a high volume of short-term catheterisation

Exclusion criteria

Exclusion criteria: 1. Patients for whom urinary catheterisation is expected to be long-term (i.e. more than 14 days) 2. Urological intervention or instrumentation within preceding seven days (e.g. catheterisation, cystoscopy, prostatic biopsy and nephrostomy insertion) 3. Non-urethral catheterisation (e.g. suprapubic catheterisation) 4. Known allergy to any of the following: latex, silver salts, hydrogel, silicone or nitrofurazone

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 25, 2026