Many people whose bladders do not empty normally use intermittent catheterisation (IC). They empty the urine from their bladder by passing a thin tube (catheter) into the bladder from time to time (intermittently).
The MultiCath Trial is the second part of a large, two-phase research programme called the MultICath Study. In Phase 1, panels of IC users worked with the study team to identify uncoated catheters, lubricants and cleaning methods that work well for them. Together we developed the methods needed for reusing catheters in the trial and to ensure that the way catheters are re-used in the trial is safe, practical and acceptable.
We interviewed many IC users about their experience of intermittent catheterisation, and about the advantages and disadvantages of single-use and multi-use catheters. They have told us there are advantages in re-using catheters at least some of the time. We asked IC users about their experiences of urinary tract infection in order to develop the questionnaires for the Trial.
In developing the trial the study team has also consulted widely with doctors, specialist nurses and other scientists. Over 200 healthcare professionals including members of the British Association of Urological Nurses completed a comprehensive survey about catheter reuse. Articles about the research programme have been published in leading medical and nursing magazines and journals. Read more here.
It is possible that using multi-use catheters some of the time and single-use catheters at other times will offer the advantages of both types. We call this 'mixed use'. But before mixed use can be recommended, we need to find out more about how multi-use catheters affect users. Therefore the purpose of the MultICath trial is to find out if multi-use catheters do not cause any more urinary tract infections (UTIs) than single-use catheters and if intermittent catheterisation users find it acceptable to clean and re-use catheters.
To do this, we need 520 IC users to agree to take part. Half of those who join the trial will continue with single-use catheters as normal. The other half will be asked to do mixed use and, for some of the time, to use special, multi-use catheters that we will give them. They will use their usual single-use catheters the rest of the time. This will be decided at random. The study will collect data from each IC user about their experiences and any problems every month for a year.
The NHS currently provides nearly all IC users with single-use catheters which are used only once and then thrown away. This means people often must carry many catheters with them and find places to dispose of them when out and about. As most intermittent catheters are made from plastic, it also means a lot of plastic being thrown away. Single-use catheters are often coated or packaged with a lubricant.
Reusable or multi-use catheters are intended to be cleaned and re-used several times before being thrown away. They are uncoated and therefore usually require the addition of a lubricant for use.
The MultiCath Trial will start in Spring 2020. It is hoped that the trial will be completed in three years. Each IC user taking part in the trial will be involved for one year and two weeks.
The MultiCath Trial aims to answer this question. Currently, there is no clear, published evidence that using reusable catheters is more likely to cause more urinary tract infections than using only single use catheters. Nor is there clear evidence for which method people find most convenient or satisfactory.
During the trial, IC users who are asked to use reusable catheters will be instructed in the Multicath Milton cleaning method. The study team will check whether this is being done properly throughout the trial.
Comparing the safety and acceptability of single-use and multi-use catheters was one of the top ten research priorities identified in 2008 by the James Lind Alliance, a collaboration of 13 clinician organisations and 8 patient and carer organisations who worked together to prioritise research in the area of incontinence and bladder management.
Some people have reported that there are advantages to re-using catheters, but re-use is no longer offered as an option in the UK. If the Trial shows that it is safe and acceptable it may become available as an option, thereby increasing patient choice. With the current focus on a reduction in use of single-use, plastic products in healthcare, a thorough evaluation of the potential for reusable intermittent catheters is very timely.
In addition, although the trial is UK based and funded, health care research is an international activity, with people in one country often benefiting from research in another. The trial will provide much needed evidence about the safety of re-usable catheters and about effective and safe cleaning and storage methods. This evidence will help many IC users around the world who use reusable catheters.
The MultICath Trial is testing mixed use of catheters (multi-use and single use) rather than either multi-use or single use catheters. Thus the researchers would not be recommending to the NHS that individuals ONLY reuse catheters. A mixed package of single and multi-use offers flexibility to meet the lifestyle needs of many IC users.
The trial will recruit people who use IC for many different reasons. The trial will also recruit people with and without disabilities. The results of the trial will help us to understand which types of people are more or less likely to find multi-use catheters helpful.
The whole research programme, which includes the trial, has been developed by internationally acknowledged experts in continence management. The study team and management committees include patients, medical doctors, specialist urology nurses, laboratory scientists and others. The research programme and trial have been approved and funded by the UK’s National Institute for Health Research. The research programme and trial have been approved by research ethics committees, whose job is to assess whether health research is safe, ethical, well-designed and useful, and the Health Research Authority.
Understanding the views of health service users is important to service developers and researchers aiming to improve health care. Involving patients and the public in the conduct of research can ensure that things that really matter to patients and the public are taken into account.
In the MultICath study, patients, the public and organisations that represent them have been involved at all stages and in many different ways.
The research programme and funding proposal were developed with the collaboration of the Bladder and Bowel Foundation, then the primary UK user group focusing on continence issues, and a former Chairman of the charity is a grant-holder. Intermittent catheterisation users were also consulted about the content, direction and practicalities of the programme.
Catheter users have been interviewed in order to identify any advantages and disadvantages of single use and multi-use catheters. The same group has reported their experience of urinary infection symptoms and reasons for seeking medical help relating to catheterisation in order to develop the questionnaire that will be used during the clinical trial. This is so that the trial results will reflect real user’s experience of intermittent catheterisation rather than factors decided upon only by researchers.
Another panel of users was formed to develop and test the cleaning and storage methods that will be used for multi-use catheters during the trial. This is intended to ensure that the multi-use method is practical and acceptable and can easily be fitted into the everyday lives of trial participants.
Throughout the duration of the research programme, intermittent catheterisation users are being included in the Project Management Group, which will oversee the direct management of the research. There is also user representation on the independent Programme Steering Committee, which takes a broader overview of the research programme and reports to the National Institute for Health Research.
This website refers to independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research (PGfAR) Programme (Grant Reference Number RP-PG-0610-10078). The views expressed are those of the research team and not necessarily those of the NHS, the NIHR or the Department of Health.