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Types of urethral catheter for reducing symptomatic urinary tract infections in hospitalised adults requiring short-term catheterisation
ISRCTN ISRCTN75198618
DOI 10.1186/ISRCTN75198618
ClinicalTrials.gov identifier
EudraCT number
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
Lay summary Not provided at time of registration
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 Completed
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 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23134837
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23199586
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
  Email 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
  Email liz.rattray@abdn.ac.uk
  Sponsor website: http://www.abdn.ac.uk/R&I
Date applied 22/01/2007
Last edited 17/05/2013
Date ISRCTN assigned 26/01/2007
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