Antimicrobial urinary catheter safety study

Completed

• Conditions: Urological and Genital Diseases; Specialty: Renal disorders, Primary sub-specialty: Renal disorders; UKCRC code/ Disease: Renal and Urogenital/ Other disorders of kidney and ureter; Long-term (over 28 days) long-term urethral urinary catheter use

• Registration Number: ISRCTN12606737
• Lead Sponsor: niversity of Nottingham

Brief Summary

1. 2018 results in: https://doi.org/10.1002/nau.23858

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-23
• Study Completion: 2018-05-31
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Aged 16 years and over
2. Previously had a urethral urinary catheter for 28 days or more and will require another urethral urinary catheter for 28 days or more
3. Able to response verbally and speak on the telephone about the treatment
4. Able to understand spoken and written English and speak English fluently

Exclusion Criteria

1. Pregnancy
2. Lacking capacity to provide consent
3. Allergy to Rifampicin, Sparfloxacin (or any other fluoroquinolone antibiotic), Triclosan or Silicone
4. History of uncontrolled/unmanageable autonomic dysreflexia
5. Significantly impaired bladder and urethral sensation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of adverse events reported as attributable to the antimicrobial urinary catheter is measured through telephone interviews at 24 hours, 48 hours, 72 hours and every week until catheter removal.

Secondary Outcome Measures

Name	Time	Method
1. Type of adverse events (if reported) are measured through telephone interviews at 24 hours, 48 hours, 72 hours and every week until catheter removal<br>2. Time to event (if reported) is measured through telephone interviews at 24 hours, 48 hours, 72 hours and every week until catheter removal<br>3. Removal of catheter before the end of the trial (if reported) is measured through telephone interviews at 24 hours, 48 hours, 72 hours and every week until catheter removal<br>4. Overall patient acceptability is measured through telephone interviews at 24 hours, 48 hours, 72 hours and every week until catheter removal<br>5. Catheter efficacy will be determined by collecting the trial device at the end of the trial, and examining the attached bacteria in the laboratory using standard microbiological culture techniques at study end<br>