Our primary route for recruitment is through General Practices as Participant Identification Centres (PIC), using prescribing records to identify potential participants, and asking the practices to mail out invitation packs to potential participants.
If you are interested in taking part please contact the MultICath team.
You will be asked to:
Search your database to identify eligible patients that could be invited to participate
Mail out invitation packs to potential participants - these comprise a covering letter, a study invitation, a participant information sheet, an expression of interest form and a reply-paid envelope. A repeat mail out may be requested.
Check participant notes when necessary to corroborate information from participants.
Our research nurse will support your practice during these activities. We will provide all the invitation packs and we will do the consenting, randomisation and follow-up of each of the participants.
Taking part will not mean a great deal of work for your practice. Service support costs will be paid via the Clinical Research Network and research costs will be paid by the University of Southampton.
Patients who take part will have the opportunity to try out a different type of catheter and catheter regime which they may find beneficial. They will also have much closer supervision of their IC during the trial than is usual practice.
Participants randomised to the control arm will continue with their usual catheter type and will not require any additional products for catheterisation. You would continue to prescribe these as usual practice.
Participants in the intervention arm will use single use and multi-use catheters (mixed use). They will be given all the items they require for doing multi-use by their research nurse. These include reusable catheters and other items for cleaning, lubrication and storage of the catheters. We will ensure participants are not out of pocket. As the frequency with which people catheterise varies, the quantities of these products will be supplied on an individual basis to meet each participant’s needs. These participants will also continue to need a supply of their usual single use catheters which you would continue to prescribe as usual practice.
Participants in the intervention arm will be given detailed guidelines on how to use the reusable catheters in the Multicath Trial. This information will be provided as a booklet and video available via a web link and on DVD/usb key. The guidelines have been developed from work done in the cleaning module of Phase 1 of the Programme and from instructions for use provided by the manufacturers of the catheters and other items to be used.
Participants in both arms will also be given detailed information about what to do if they suspect they have a urinary tract infection. Trial specimens will be sent by participants to the trial laboratory. They will only be analysed for the purpose of establishing urinary tract infection for the primary outcome. This urine will not be cultured or GPs informed of the results. Participants are advised to also follow their usual local procedures e.g. sending a specimen to their GP.
Trial catheter
The catheter type being used in the Multicath Trial is called the Cliny catheter. It is an uncoated, silicone, intermittent catheter which comes in a kit with a storage tube, and as a separate catheter. Although it is not available on the UK Drug Tariff, it is CE-marked (licenced) for re-use when cleaned between uses with Milton over a period of up to 28 days and is used in several countries worldwide (e.g. Japan, Australia and South Africa). As it is uncoated, it should be used with a suitable lubricant for passage through the urethra.
The Cliny catheter is being used according to its licence and therefore the Multicath Trial does not require MHRA approval.
Participants
Participants will be men and women who use intermittent catheterisation for bladder emptying. For this pragmatic trial we have few exclusion criteria because we want to include participants from all major groups of intermittent catheterisation users (including those receiving IC from a single informal carer). We expect most patients to be using single-use, hydrophilic-coated catheters at recruitment but type of catheter in current use will not determine study entry.
Inclusion criteria:
Exclusion criteria:
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.