The MultICath Study
| ISRCTN | ISRCTN68472863 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68472863 |
| Secondary identifying numbers | 20506 |
- Submission date
- 09/03/2016
- Registration date
- 10/03/2016
- Last edited
- 12/08/2019
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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)
Contact information
Public
University of Southampton
Southampton
-
United Kingdom
Scientific
Newcastle University
Newcastle Clinical Trials Unit
1-4 Claremont Terrace
Newcastle upon Tyne
NE2 4AE
United Kingdom
Study information
| Study design | Multi-centre randomised parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Development and Clinical Trial of a Mixed (Multi/Single-use) Catheter Management Package for Users of Intermittent Catheterisation (The MultICath Study) |
| Study acronym | MultICath |
| Study objectives | 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(s) | 15/SC/0433 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/03/2016 |
| Completion date | 31/03/2017 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 500; UK Sample Size: 500 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2016 |
| Date of final enrolment | 31/03/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Archway Campus
2-10 Highgate Hill
London
N19 5LW
United Kingdom
Sponsor information
University/education
University Road
Southampton
SO17 1BJ
England
United Kingdom
"ROR" |
https://ror.org/01ryk1543 |
|---|
Funders
Funder type
Government
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 date | 31/03/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
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.
