Condition category
Urological and Genital Diseases
Date applied
23/01/2017
Date assigned
23/01/2017
Last edited
13/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 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

01/06/2016

Overall trial end date

31/05/2018

Reason abandoned

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.