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The University of Southampton
The MultICath Trial

What do I need to know

What is the purpose of this Trial?

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 catheter use. Before mixed use can be recommended, we need to find out more about how multi-use catheters affect users. Therefore the purpose of the Mul tI Cath Trial is to find out if multi-use catheters do not cause any more urinary tract infections (UTI) than single-use catheters and if intermittent catheterisation users find it acceptable to clean and re-use their catheters.

To compare mixed catheter use with single-use catheters only, we need about 520 people who use intermittent catheterisation to agree to take part in the trial. Half of the group (approximately 260 people) will be asked to continue to use single-use catheters only and the other half will be asked to use a mixture of multi-use and single-use catheters. This will be decided at random.

Can I take part in the Trial?

You can take part in the Trial if:

You cannot take part in the Trial if:

If I contact the research team for more information, will I have to take part?

No. You do not have to take part unless you want to and it should be your decision. If you contact us for more information we will first find out whether you are eligible to take part. If so, a member of our research team will go through this information with you. You will be given as much time as you like to think about your decision. You will then have a chance to have further questions answered.

If you agree to take part we will ask you to sign a consent form. If you change your mind later, you can withdraw from the trial at any time. You do not have to give a reason for withdrawing. A decision not to take part will not affect the care you receive from your doctors and nurses.

What will happen if I agree to take part?

If you join the trial, you will be asked to either use single-use catheters only OR to use a mixture of multi-use and single-use catheters. The choice between the two options will be decided at random by a computer. The randomization programme acts like flipping a coin.

If you are asked to use a mixture of multi-use and single-use catheters, you will be taught about catheter cleaning and storage techniques that have been tested and shown to be safe when used by panels of men and women. You will be given all the items and information you need to catheterise with multi-use catheters including a booklet and video.

If I join the Trial must I re-use catheters all the time?

Panels of patients have worked with the trial team to develop an approach to re-using catheters that is flexible, acceptable and practical. We recognise that intermittent catheterisation must fit in with people's lives, concerns and routines. Therefore, although people will be asked to try to catheterise with multi-use catheters at least 50% of the time, nobody will be obliged to so do if it is not convenient.

Will it be complicated using single use catheters sometimes and re-using catheters at other times?

In the first two years of the research programme, intermittent catheterisation users have tried mixed use. They have found that there are advantages and disadvantages to both. They have taken advantage of the flexibility of being able to use each type at different times to suit their lifestyle Listen to catheters users talking about doing mixed use.

The trial will take note of how participants use their catheters and any problems they may encounter. At the end of the trial we will interview a group of participants who used single-use catheters sometimes and re-used other catheters at other times about their experiences and preferences having completed the Trial. We will also speak to informal carers who are involved with the catheterisation of our participants.

What will I have to do during the Trial?

You would have to do intermittent catheterisation according to the regime selected for you. Regardless of which group you are in, you will be asked to do the following:

At the start of the trial :

This visit will take up to two hours.

Every month during the trial :

At the end of the trial :

All activities related to the trial will take place in your own home (or your hospital clinic in exceptional circumstances) and during your normal everyday activities.

After the Trial:

You will be required to continue intermittent catheterisation with your usual single-use catheters. Regardless of the results of the trial, we will not be able to recommend multi-use of intermittent catheters unless they become available for prescription by your GP.

Current guidance from the National Institute for Health and Care Excellence (NICE) does not recommend the use of multi-use catheters. This is not because they are known to cause more urine infections than single-use catheters but because multi-use catheters are not available in the UK.

Expenses and payments

We will provide all equipment that you need for taking part in the trial. You may keep any equipment you have at the end of the trial although, as stated above, we will not be able to recommend that you do multi-use catheterisation as the multi-use catheters are not currently available in the UK.

What are the benefits of taking part?

The chance to try different catheters. The main benefit of taking part is that, if you are doing mixed catheter use, you will have an opportunity to try an alternative way of managing your intermittent catheterisation, one which is unlikely to be available to you otherwise. Re-use of catheters remains common in some parts of the world. Research has shown that there are advantages and disadvantages to both multi-use and single-use catheters and that mixed use may offer the best of both types of catheterisation and be preferred by users.

Close supervision. During the Trial you will be under closer follow-up than usual and may learn more about intermittent catheterisation from the information we will give you. Whichever group you are allocated to, you will be helping to improve our understanding of intermittent catheterisation with multi-use catheters. If we find that re-using catheters causes no more urinary tract infection than using single-use catheters only and intermittent catheterisation users prefer them at least some of the time, re-use of intermittent catheters may once again become part of clinical practice.

What are the disadvantages or risks of taking part?

It is possible that you might experience a urinary tract infection.  It is a commonly held thought that use of sterile catheters prevents bacteria entering the bladder and causing urinary tract infection (UTI) and keeps bacteria out of the urinary tract. In fact IC users often have several different types of bacteria in their bladder and develop UTIs even when they only use sterile catheters. Current research does not show that re-using a catheter causes more UTI than only using sterile ones.

It is possible that you might experience some discomfort or skin soreness when testing the catheters, but this is a risk with all catheters. We will be asking you for feedback about this throughout the Trial. All the multi-use catheter types you will be using will have gone through rigorous laboratory testing to find the safest and most effective cleaning methods.

As well as finding out about mixed-use and urinary tract infections (UTI), we also want to find out  what users think about mixed-use of catheters and if they find it acceptable to clean and re-use their catheters.

What will happen if I don’t want to carry on with the Trial?

You can withdraw from the Trial at any time. You do not have to give a reason. If you withdraw, we would like to use the information you have already given us for our research. We would need your permission to do this if you decide to withdraw.

What if there is a problem?

If you have a concern about any aspect of the Trial, you should ask to speak to a member of the research team first who will do their best to answer your questions.

If you remain unhappy and wish to complain formally, you can do this through the National Health Service complaints procedure. Details can be obtained from the Patient Advice and Liaison Service ( PALS ) for your local hospital. You will be provided with their contact details if you join the study.

In the unlikely event that something does go wrong and you are harmed during the research and this is due to someone’s negligence, then you may have grounds for legal action for compensation against the NHS Trust that treated you or the Trial’s sponsor organisation, the University of Southampton. However, you may have to pay your legal costs. The normal NHS complaints mechanisms will always be available to you.

Will my taking part in the Trial be kept confidential?

Yes. If you take part in the Trial, all information and related health records collected will remain strictly confidential. Any information from which you could be identified, such as your name and address, will be kept securely on paper and electronically at your research nurse’s base (usually a hospital or university), and at the main trial office in the Newcastle Clinical Trials Unit at Newcastle University.

Your contact details will be kept securely and will only be available to people involved in the Trial who need to know – for example, so that we can stay in touch regarding your progress and send you the Trial questionnaires for you to complete. Your name and address, or any details that could be used to identify you, will not be included in any paper or electronic materials outside of the Trial offices.

You will be allocated a Trial number, which will be used as a code to identify you on Trial forms and in the databases that we will use for analysing the data.

The information that we collect during your participation in the Trial will be available to people authorised to work on the Trial. It may also be made available to people authorised by the University of Southampton, the Sponsor organisation, which is responsible for ensuring that the Trial is carried out correctly. By signing the Trial consent form you agree to this access for the current Trial and any further research that may be conducted in relation to it, even if you withdraw from the current Trial.

The National Institute for Health Research, which is funding the Trial, requires that after completion of the Trial we must share the data we collect with the rest of the research community. This is so that the data can be used to help inform other research and policy development. No information that can identify you will be shared and your confidentiality will be maintained. We will use secure electronic systems for transferring data.

In line with the Sponsor regulations, at the end of the study your data will be securely stored for 10 years. Arrangements for confidential destruction will then be made.

Will my GP be informed of my involvement?

Yes, with your permission.

Do my doctors and nurses know about the Trial?

Because the Trial will take place only in certain regions with the UK, it is likely that awareness may be higher there. But doctors and nurses throughout the UK have been consulted during the research programme, and many may read articles in leading medical and nursing publications.

What will happen to the results of the research Trial?

The results will be presented at research meetings, and published on the National Institute for Health Research website and in scientific journals. We will also make the results widely available to the public using the Trial website. You will not be identified in any report or publication.

Who is organising and funding the research?

This study is being organised by the Newcastle University Clinical Trials Unit. It is sponsored by the University of Southampton on behalf of Solent NHS Trust, and funded by the National Institute for Health Research Programme Grant for Applied Research.

Who has approved the Trial?

All research in the NHS is looked at by an independent group of people called a Research Ethics Committee to protect your interests. The MultICath trial has been approved by a local Research Ethics Committee and the Health Research Authority.

Have patients and the public been involved in the development and conduct of the Trial?

Understanding the views of health service users is important to those who are trying to provide and develop those services and to those who do research that aims 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 research programme, 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, the former 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. 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 has been 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 have been included in the Project Management Group, which oversees the direct management of the research. There is also user representation on the Programme Steering Committee, which will take a broader overview of the research programme and report 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.

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