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| [ ...Back to search results ] | [ Print-friendly version ] |
| Types of urethral catheter for reducing symptomatic urinary tract infections in hospitalised adults requiring short-term catheterisation |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN75198618 |
| Date ISRCTN assigned | 26/01/2007 |
| Local reference number(s) | HTA 05/46/01 |
| Public title | Types of urethral catheter for reducing symptomatic urinary tract infections in hospitalised adults requiring short-term catheterisation |
| Scientific title | |
| Acronym | CATHETER |
| Disease/condition/study domain | Urinary tract infections |
| 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%). |
| Design/methodology | Three-arm randomised controlled trial |
| Research ethics review | Approval was issued from the Grampian Local Research Ethics Committee (1) on 7th December 2006 (ref: 06/S0801/110). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Adult patients (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 |
| Patient information material | Patient information can be found at: https://www.charttrials.abdn.ac.uk/catheter/patientInfo.php |
| Anticipated start date | 01/02/2007 |
| Anticipated end date | 31/10/2009 |
| Status of trial | Ongoing |
| 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) | 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 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 |
| Trial website | https://www.charttrials.abdn.ac.uk/catheter/ |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | University of Aberdeen (UK) |
| Sponsor details | Research and Innovation King's College Aberdeen United Kingdom AB24 3FX |
| Sponsor telephone | +44 (0)1224 272123 |
| Sponsor fax | +44 (0)1224 272319 |
| Sponsor email | liz.rattray@abdn.ac.uk |
| Sponsor website | http://www.abdn.ac.uk/R&I |
| Contact name | Prof James N'Dow |
| Contact details | Academic Urology Department 1st Floor Health Sciences Building Foresterhill Aberdeen United Kingdom ABS5 2ZD |
| Contact telephone | +44 (0)1224 553014 |
| Contact fax | +44 (0)1224 554580 |
| Contact email | j.ndow@abdn.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN75198618 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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