Plain English Summary
Background and study aims
Urinary catheterisation is a procedure used to drain the bladder and collect urine, through a thin, flexible tube called a catheter. It involves the catheter being passed into the bladder via the urethra (the tube through which urine passes) so that the urine in the bladder can be drained into a collecting bag. Some patients require catheters to be in place long-term. Long-term (over 28 days) 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. This study will look at catheters that have been treated with three types of antimicrobial (killing microorganisms such as bacteria) drugs can prevent bacteria from attaching to the catheter to prevent infection. The aim of this study is to find out whether there are any side-effects associated with use of antimicrobial urinary catheters.
Who can participate?
Patients aged 16 years or over who have previously had a urinary catheter for at least 28 days and need another urinary catheter to be put in place for at least 28 days.
What does the study involve?
When participants are next due to have their long-term urinary catheter put in place, the antimicrobial urinary catheter is inserted (following standard procedures). Participants are then interviewed by telephone after 24, 48 and 72 hours and then weekly until the catheter is removed about their experience with the antimicrobial catheter. The catheter stays in place for the length of time needed for each individual patient. When the catheter is removed, it is sent to the lab so that bacteria levels can be tested. Participants are also interviewed at the end of the study to find out if it would be feasible to conduct a larger study.
What are the possible benefits and risks of participating?
There is no guarantee of direct benefits for those participating, however the catheters used in the study could prevent the development of CAUTI. There are no direct risks of participating other than the general risks involved with having a catheter.
Where is the study run from?
Queen's Medical Centre, Nottingham (UK)
When is the study starting and how long is it expected to run for?
June 2016 to May 2018
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Miss Katherine Belfield
Miss Katherine Belfield
Department of Academic Orthopaedics
and Sports Medicine
Queen's Medical Centre
+44 1158 231113
A novel antimicrobial urinary catheter for long-term catheter users: a study of its safety
The aim of this study is to determine whether the addition of three antimicrobials to a silicone urinary catheter produces any side effects when used in patients.
East Midlands - Edgbaston Research Ethics Committee, 12/09/2016, ref: 16/WM/0353
Non-randomised; Interventional; Design type: Prevention, Device
Primary study design
Secondary study design
Non randomised study
Patient information sheet
See additional files
Specialty: Renal disorders, Primary sub-specialty: Renal disorders; UKCRC code/ Disease: Renal and Urogenital/ Other disorders of kidney and ureter
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 (i.e. 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.
Primary outcome measures
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
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
2. Time to event (if reported) is measured through telephone interviews at 24 hours, 48 hours, 72 hours and every week until catheter removal
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
4. Overall patient acceptability is measured through telephone interviews at 24 hours, 48 hours, 72 hours and every week until catheter removal
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
Overall trial start date
Overall trial end date
Participant 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
Target number of participants
Planned Sample Size: 60; UK Sample Size: 60
Participant exclusion criteria
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
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Queen's Medical Centre
Nottingham University Hospitals NHS Trust Derby Road
University of Nottingham
and Graduate Services
Kings Meadow Campus
+44 1158 467906
National Institute for Health Research
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Results will be published in a relevant journal and lay materials will be distributed to trial participants at the end of the trial.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from Miss Katherine Belfield at Katherine.email@example.com.
Intention to publish date
Participant level data
Available on request
Results - basic reporting
- ISRCTN12606737_PIS_26Aug16_V2.0.pdf Uploaded 24/01/2017