The MultICath Study
Research type
Research Study
Full title
Development and Clinical Trial of a Mixed (Multi/Single-use) Catheter Management Package for Users of Intermittent Catheterisation (The MultICath Study)
IRAS ID
177507
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, 0 months, 1 days
Research summary
The MultICath trial is about finding out whether people who use intermittent catheterisation 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 at least 520 people who are carrying out intermittent catheterisation. Half will be randomised to using single use catheters only, the other half will be randomised to using a combination of single use and multi use catheters for 12 months. Everybody who agrees to take part in the study will be asked to fill out a series of questionnaires about their catheter use, any urinary tract infections they might experience and their general health over a year. They will also be asked to provide regular urine specimens.
The study has been funded with a NIHR Programme Grant for Applied Research and participants will initially be recruited from five sites across the UK
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
15/SC/0433
Date of REC Opinion
20 Oct 2015
REC opinion
Further Information Favourable Opinion