ISRCTN ISRCTN12606737
DOI https://doi.org/10.1186/ISRCTN12606737
Secondary identifying numbers 33365
Submission date
23/01/2017
Registration date
23/01/2017
Last edited
29/10/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Miss Katherine Belfield
Public

Department of Academic Orthopaedics, Trauma, and Sports Medicine
C Floor, West Block
Queen's Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

ORCiD logoORCID ID 0000-0001-5893-0882
Phone +44 1158 231113
Email katherine.belfield@nottingham.ac.uk

Study information

Study designNon-randomised; Interventional; Design type: Prevention, Device
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet ISRCTN12606737_PIS_26Aug16_V2.0.pdf
Scientific titleA novel antimicrobial urinary catheter for long-term catheter users: a study of its safety
Study objectivesThe 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(s)East Midlands - Edgbaston Research Ethics Committee, 12/09/2016, ref: 16/WM/0353
Health condition(s) or problem(s) studiedSpecialty: Renal disorders, Primary sub-specialty: Renal disorders; UKCRC code/ Disease: Renal and Urogenital/ Other disorders of kidney and ureter
InterventionConsenting 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 typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureRate 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 measures1. 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 study start date01/06/2016
Completion date31/05/2018

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit16 Years
SexBoth
Target number of participantsPlanned Sample Size: 60; UK Sample Size: 60
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/12/2016
Date of final enrolment20/11/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Queen's Medical Centre
Nottingham University Hospitals NHS Trust
Derby Road
Nottingham
NG7 2UH
United Kingdom

Sponsor information

University of Nottingham
University/education

Research, Enterprise, and Graduate Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom

Phone +44 1158 467906
Email sponsor@nottingham.ac.uk
ROR logo "ROR" https://ror.org/01ee9ar58

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date31/12/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planResults will be published in a relevant journal and lay materials will be distributed to trial participants at the end of the trial.
IPD sharing planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version V2.0 26/08/2016 24/01/2017 No Yes
Results article results 01/01/2019 Yes No
HRA research summary 28/06/2023 No No

Additional files

ISRCTN12606737_PIS_26Aug16_V2.0.pdf
Uploaded 24/01/2017

Editorial Notes

29/10/2018: Publication reference added.
13/11/2017: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting.