Antimicrobial urinary catheter safety study
Research type
Research Study
Full title
A novel antimicrobial urinary catheter for long-term catheter users: a study of its safety
IRAS ID
206184
Contact name
Katherine Belfield
Contact email
Duration of Study in the UK
0 years, 11 months, 27 days
Research summary
Long-term urinary catheter users are at risk of catheter-associated urinary tract infections (CAUTI). This can mean courses of antibiotics, early removal of the catheter, blockage of the catheter, and other serious complications for patients. We have added to exisiting, licensed silicone urinary catheters three antimicrobial drugs which prevent bacteria from attaching to the catheter to prevent infection. Laboratory studies show that this antimicrobial catheter can prevent catheter colonisation by the main bacteria that cause CAUTI for 7-12 weeks. In order to bring this catheter to long-term catheter users we need to understand if there are any side effects associated with the antimicrobial urinary catheter.
Therefore, we plan to undertake an initial study of the safety of this antimicrobial urinary catheter in 60 adult, long-term urinary catheters users (those patients who have had a catheter in place for at least 28 days and will require another for at least 28 days) from Nottingham University Hospitals Trust. Consenting participants will receive the antimicrobial urinary catheter at their next planned catheter insertion, and will be asked to answer questions regarding experience with the antimicrobial catheter via 15 minute telephone interviews at 24 hours, 48 hours, 72 hours and every week after the catheter is inserted. The participants' involvement will range from 28 days to 84 days depending on their normal catheterisation schedule (ie if they have their catheter changed every 6 weeks, the antimicrobial catheter will remain in place for 6 weeks). The participants will also be asked to fill in a questionnaire about their interest and understanding of a future randomised controlled trial which will inform the sample size calculation and feasibility for this future study. Finally, at the end of the trial when the catheter is removed, it will be collected and analysed in the laboratory for bacterial attachment.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
16/WM/0353
Date of REC Opinion
12 Sep 2016
REC opinion
Further Information Favourable Opinion