MultICath
Research type
Research Study
Full title
A non-inferiority randomised controlled trial to compare mixed (multi/single-use) catheter management with single-use catheter management by intermittent catheter users over 12 months
IRAS ID
252496
Contact name
Mandy Fader
Contact email
Sponsor organisation
University of Southampton
Clinicaltrials.gov Identifier
RP-PG-0610-10078, NIHR Programme Grant for Applied Research
Duration of Study in the UK
3 years, 3 months, 31 days
Research summary
The MultICath trial is about finding out whether people who use intermittent catheterisation (IC) to empty their bladder experience no more urinary tract infections reusing some of their catheters than they would using their standard care single use catheters.
Intermittent catheterisation is commonly used by people who have difficulty emptying their bladder because of bladder muscle weakness or nerve diseases. Intermittent catheterisation is generally a very useful way to empty the bladder as it avoids having to have a catheter in all the time and protects the bladder and kidneys from further damage.
We hope to recruit 520 participants who are carrying out intermittent catheterisation from around the UK. 50% of these participants will be randomised to using single use catheters (usual care) with the other half randomised to the mixed-use strategy whereby participants will use a combination of single use and multi-use catheters for 12 months. Participants in the mixed-use arm will use a reusable silicone catheter which CE marked for reuse for some of their intermittent catheterisation.
Participants who consent and are randomised to the trial will be asked to complete a series of questionnaires about their catheter use and any urinary tract infections (UTIs) experienced over the course of the trial in addition to their general health. Participants will also be required to provide regular urine specimens at specific time points and anytime the participant suspects a UTI.
The study has been funded with a NIHR Programme Grant for Applied Research.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
19/SC/0334
Date of REC Opinion
15 Jul 2019
REC opinion
Favourable Opinion