Condition category
Urological and Genital Diseases
Date applied
22/01/2007
Date assigned
26/01/2007
Last edited
17/05/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

https://www.charttrials.abdn.ac.uk/catheter/

Contact information

Type

Scientific

Primary contact

Prof James N'Dow

ORCID ID

Contact details

Academic Urology Department
2nd Floor
Health Sciences Building
Foresterhill
Aberdeen
ABS5 2ZD
United Kingdom
+44 (0)1224 553014
j.ndow@abdn.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 05/46/01

Study information

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

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information can be found at: https://www.charttrials.abdn.ac.uk/catheter/patientInfo.php

Condition

Urinary tract infections

Intervention

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.

Intervention type

Drug

Phase

Not Specified

Drug names

Nitrofurazone and silver alloy impreganted catheters

Primary outcome measures

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

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

Overall trial start date

01/02/2007

Overall trial end date

31/10/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

5700

Participant 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

Recruitment start date

01/02/2007

Recruitment end date

31/10/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Urology Department
Aberdeen
ABS5 2ZD
United Kingdom

Sponsor information

Organisation

University of Aberdeen (UK)

Sponsor details

Research and Innovation
King's College
Aberdeen
AB24 3FX
United Kingdom
+44 (0)1224 272123
liz.rattray@abdn.ac.uk

Sponsor type

University/education

Website

http://www.abdn.ac.uk/R&I

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23134837
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23199586

Publication citations

  1. Results

    Pickard R, Lam T, MacLennan G, Starr K, Kilonzo M, McPherson G, Gillies K, McDonald A, Walton K, Buckley B, Glazener C, Boachie C, Burr J, Norrie J, Vale L, Grant A, N'Dow J, Antimicrobial catheters for reduction of symptomatic urinary tract infection in adults requiring short-term catheterisation in hospital: a multicentre randomised controlled trial., Lancet, 2012, 380, 9857, 1927-1935, doi: 10.1016/S0140-6736(12)61380-4.

  2. Results

    Pickard R, Lam T, Maclennan G, Starr K, Kilonzo M, McPherson G, Gillies K, McDonald A, Walton K, Buckley B, Glazener C, Boachie C, Burr J, Norrie J, Vale L, Grant A, N'dow J, Types of urethral catheter for reducing symptomatic urinary tract infections in hospitalised adults requiring short-term catheterisation: multicentre randomised controlled trial and economic evaluation of antimicrobial- and antiseptic-impregnated urethral catheters (the CATHETER trial)., Health Technol Assess, 2012, 16, 47, 1-197, doi: 10.3310/hta16470.

Additional files

Editorial Notes