Condition category
Urological and Genital Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status

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 Margaret Macaulay (public)
2. Dr Alexander von Wilamowitz-Moellendorff (scientific)

Trial website

Contact information



Primary contact

Ms Margaret Macaulay


Contact details

University of Southampton
United Kingdom



Additional contact

Dr Alexander von Wilamowitz-Moellendorff


Contact details

Newcastle University
Newcastle Clinical Trials Unit
1-4 Claremont Terrace
Newcastle upon Tyne
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


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)



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


Study design

Multi-centre randomised parallel trial

Primary study design


Secondary study design

Randomised parallel trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: Primary Care, Renal; Subtopic: Primary Care (Renal Disorders), Renal (Renal Disorders); Disease: All Diseases, All Renal Disorders


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



Drug names

Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)

Objectives no longer viable


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University College London
Department of Medicine Clerkenwell building Archway Campus 2-10 Highgate Hill
N19 5LW
United Kingdom

Sponsor information


University of Southampton

Sponsor details

University Road
SO17 1BJ
United Kingdom

Sponsor type




Funder type


Funder name

National Institute for Health Research

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

National government


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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/08/2019: The trial was halted in September 2016 to obtain a CE marked reusable catheter for use in the trial. 09/08/2019: The public contact's details have been updated. 18/10/2017: Internal review.