Plain English Summary
Background and study aims
Intermittent (‘in-out’) catheterisation is a technique used by people who have difficulty emptying their bladder. It involves a thin tube being passed into the bladder via the urethra (the tube through which urine passes) so that the urine in the bladder can be drained when needed (intermittently). Traditionally, intermittent catheters could be cleaned and reused, often for several days or longer (multi-use catheters). Since then, catheters have been developed that are intended to be used once only and then thrown away (single-use). Most people in the UK use single-use catheters now and multi-use catheters are not readily available any more. One of the most common complications of intermittent catheterisation is that users often develop urinary tract infections, UTIs (water infections). Many believe that using multi-use catheters is more likely to cause UTIs, however there is little research supporting this claim. The aim of this study is to find out whether using a mixture of multi-use catheters and single-use catheters (mixed-use) is just as safe as using only single-use catheters, and whether it is acceptable to users.
Who can participate?
Patients aged 16 and over, who are currently using or are planning to use intermittent catheterisation for the next 12 months.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are asked to use single-use catheters only over a course of 12 months. Those in the second group are asked to use a mixture of multi-use and single-use catheters for the same length of time. Participants in this group are taught about safe catheter cleaning and storage techniques. Once a month during the study, participants are interviewed by a research nurse over the telephone about any UTI symptoms experienced in the past month. At the end of the study, the amount of UTIs experienced by patients in each group is compared.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
University College London (UK)
When is the study starting and how long is it expected to run for?
March 2016 to March 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
1. Ms Margret Macaulay (public)
2. Dr Alexander von Wilamowitz-Moellendorff (scientific)
Trial website
Contact information
Type
Public
Primary contact
Ms Margret Macaulay
ORCID ID
Contact details
University College London
Department of Medicine Clerkenwell building
Archway Campus
2-10 Highgate Hill
London
N19 5LW
United Kingdom
Type
Scientific
Additional contact
Dr Alexander von Wilamowitz-Moellendorff
ORCID ID
Contact details
Newcastle University
Newcastle Clinical Trials Unit
1-4 Claremont Terrace
Newcastle upon Tyne
NE2 4AE
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
20506
Study information
Scientific title
Development and Clinical Trial of a Mixed (Multi/Single-use) Catheter Management Package for Users of Intermittent Catheterisation (The MultICath Study)
Acronym
Study hypothesis
The aim of this study is to find out whether using a mixture of single-use and multi-use catheters is acceptable to users and no more likely to cause urinary tract infection or other problems than using single-use catheters only.
Ethics approval
15/SC/0433
Study design
Multi-centre randomised parallel trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Primary Care, Renal; Subtopic: Primary Care (Renal Disorders), Renal (Renal Disorders); Disease: All Diseases, All Renal Disorders
Intervention
Participants are randomly allocated to one of two groups.
Group 1: Participants use a mixture of single-use and multi-use catheters for 12 months.
Group 2: Participants use single-use catheters only for 12 months.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Symptomatic urinary tract infection rate rate is measured over 12 months through monthly telephone interviews.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/2016
Overall trial end date
31/03/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 16 years and over
2. Intermittent catheterisation planned to continue for 12 months
3. Able and willing to adhere to a 12-month follow up period
4. Currently using or preparing to start using intermittent catheterisation (via the urethra), performed by self or sole carer
5. Patient has provided written informed consent for participation in the study prior to any study specific procedures
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 500; UK Sample Size: 500
Participant exclusion criteria
1. Aged below 16 years
2. Use of IC for self-dilatation of urethral stricture (ISD) without bladder drainage
3. Non-urethral route for catheterisation e.g. Mitrofanoff
4. External carer required for IC (i.e. where sterile technique and catheter is required e.g. visiting community nurse performs IC)
5. Inability to give informed consent or have primary outcome information collected
6. Women who are pregnant, planning to become pregnant or breast feeding during the trial
Recruitment start date
01/03/2016
Recruitment end date
31/03/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London
Department of Medicine Clerkenwell building
Archway Campus
2-10 Highgate Hill
London
N19 5LW
United Kingdom
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
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary