Condition category
Urological and Genital Diseases
Date applied
09/03/2016
Date assigned
10/03/2016
Last edited
10/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://www.southampton.ac.uk/multicath/index.page

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

Sponsor information

Organisation

University of Southampton

Sponsor details

University Road
Southampton
SO17 1BJ
United Kingdom

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes