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
katherine.belfield@nottingham.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Miss Katherine Belfield
ORCID ID
http://orcid.org/0000-0001-5893-0882
Contact details
Department of Academic Orthopaedics
Trauma
and Sports Medicine
C Floor
West Block
Queen's Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
+44 1158 231113
katherine.belfield@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
33365
Study information
Scientific title
A novel antimicrobial urinary catheter for long-term catheter users: a study of its safety
Acronym
Study hypothesis
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.
Ethics approval
East Midlands - Edgbaston Research Ethics Committee, 12/09/2016, ref: 16/WM/0353
Study design
Non-randomised; Interventional; Design type: Prevention, Device
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
See additional files
Condition
Specialty: Renal disorders, Primary sub-specialty: Renal disorders; UKCRC code/ Disease: Renal and Urogenital/ Other disorders of kidney and ureter
Intervention
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.
Intervention type
Device
Phase
Drug names
Primary outcome measure
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
01/06/2016
Overall trial end date
31/05/2018
Reason abandoned (if study stopped)
Eligibility
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 60; UK Sample Size: 60
Participant 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
Recruitment start date
01/12/2016
Recruitment end date
20/11/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen's Medical Centre
Nottingham University Hospitals NHS Trust
Derby Road
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
University of Nottingham
Sponsor details
Research
Enterprise
and Graduate Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom
+44 1158 467906
sponsor@nottingham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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.belfield@nottingham.ac.uk.
Intention to publish date
31/12/2018
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN12606737_PIS_26Aug16_V2.0.pdf Uploaded 24/01/2017