Our primary route to recruitment is through General Practices. However, we are also recruiting patients through secondary care services where patients commonly use intermittent catheterisation (e.g. urology, uro-gynaecology, spinal cord injury and neuro-rehabilitation) and where our Principal Investigators already have strong relationships.
If you are interested in taking part please contact the MultICath team.
What will happen if your service expresses an interest in taking part?
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.
How would we help you?
Our research nurses will provide you with the invitation packs. Those patients who are interested will be asked to reply directly to the research nurse using the expression of interest form and a reply-paid envelope, or by telephone or email. The research nurse will contact interested patients to discuss the study, answer any questions and confirm eligibility. We will do all the other research activities (consenting, randomisation and follow-up).
Patients who are being taught intermittent catheterisation for the first time may be informed about the study by departmental staff (consultants, nurses or administrative staff) but cannot be approached to participate until they have been doing IC for 6 weeks or more.
What are the benefits to the service?
Taking part will not mean a great deal of work for your service. Service support costs will be paid via the Clinical Research Network and research costs will be paid by the University of Southampton.
What are the benefits to the participants?
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.
Products
Participants randomised to the control arm will continue with their usual catheter type and will not require any additional products for catheterisation. They will continue to obtain these as usual practice.
Participants in the intervention arm will be given all the products they require by the 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.
Participants re-using catheters will be given detailed guidelines on how to use them in the Multicath Trial. This 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 and 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. We will supply particpants with lubricant.
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.