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| Types of urethral catheter for reducing symptomatic urinary tract infections in hospitalised adults requiring short-term catheterisation |
| ISRCTN | ISRCTN75198618 |
| ClinicalTrials.gov identifier | |
| Public title | Types of urethral catheter for reducing symptomatic urinary tract infections in hospitalised adults requiring short-term catheterisation |
| Scientific title | Types of urethral catheter for reducing symptomatic urinary tract infections in hospitalised adults requiring short-term catheterisation: a randomised controlled trial |
| Acronym | CATHETER |
| Serial number at source | HTA 05/46/01 |
| Study hypothesis |
The hypothesis being tested is that use of either of the impregnated catheters will reduce the incidence of catheter associated symptomatic urinary tract infection by 40% relative to the standard PolyTetraFluoroEthylene (PTFE) coated latex catheter (an absolute reduction of around 3%).
Please note that the following amendments have been made to this trial record as of 06/05/2009: 1. The scientific title has been added 2. The anticipated end date of the trial has been updated from 31/10/2009 to 31/10/2010 |
| Ethics approval | Approval was issued from the Grampian Local Research Ethics Committee (1) on 7th December 2006 (ref: 06/S0801/110). |
| Study design | Three-arm randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Urinary tract infections |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/02/2007 |
| Anticipated end date | 31/10/2010 |
| Status of trial | Ongoing |
| Patient information material | Patient information can be found at: https://www.charttrials.abdn.ac.uk/catheter/patientInfo.php |
| Target number of participants | 5700 |
| 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 minimised by age, sex, and whether or not participants received prophylactic or concurrent antibiotic treatment.
There are two experimental groups managed with: 1. Silver alloy impregnated hydrogel urethral catheter. 2. Nitrofurazone impregnated silicone urethral catheter. The control group is managed with a PTFE coated latex urethral catheter - the ‘standard’ control. |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | https://www.charttrials.abdn.ac.uk/catheter/ |
| Publications | |
| Contact name | Prof James N'Dow |
| Address |
Academic Urology Department
2nd Floor Health Sciences Building Foresterhill |
| City/town | Aberdeen |
| Zip/Postcode | ABS5 2ZD |
| Country | United Kingdom |
| Tel | +44 (0)1224 553014 |
| Fax | +44 (0)1224 554580 |
| j.ndow@abdn.ac.uk | |
| Sponsor | University of Aberdeen (UK) |
| Address |
Research and Innovation
King's College |
| City/town | Aberdeen |
| Zip/Postcode | AB24 3FX |
| Country | United Kingdom |
| Tel | +44 (0)1224 272123 |
| Fax | +44 (0)1224 272319 |
| liz.rattray@abdn.ac.uk | |
| Sponsor website: | http://www.abdn.ac.uk/R&I |
| Date applied | 22/01/2007 |
| Last edited | 15/05/2009 |
| Date ISRCTN assigned | 26/01/2007 |
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