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

Completed

• Conditions: rinary tract infections; Urinary tract infections; Urological and Genital Diseases

• Registration Number: ISRCTN75198618
• Lead Sponsor: niversity of Aberdeen (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-26
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 5700

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measures as of 15/05/2009:<br>Primary clinical outcome measure:<br>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.<br><br>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. <br><br>Previous primary outcome measures:<br>Incidence of symptomatic urinary tract infection up to six weeks post catheter insertion (number of participants with at least one occurrence).