Cliny catheter evaluation v1.0
Research type
Research Study
Full title
Laboratory and user evaluation of a re-usable silicone intermittent urinary catheter (Cliny clean intermittent catheterisation kit)
IRAS ID
244978
Contact name
Mandy Fader
Contact email
Sponsor organisation
University of Southampton
Duration of Study in the UK
0 years, 4 months, 30 days
Research summary
Is the re-usable Cliny silicone intermittent catheter safe and acceptable to intermittent catheter users?
Intermittent catheterisation (IC) is standard treatment for incomplete bladder emptying. IC catheters were once routinely re-used multiple times. The introduction of hydrophilic coated catheters, a lack of evidence-based cleaning guidance and a belief that single use prevents urinary tract infection (UTI) has led to almost all IC catheters being licenced for single use only. However, evidence linking catheter type with UTI is inconclusive, catheter users have reported advantages to both methods and there are potential cost benefits.
In laboratory testing, two cleaning methods, Milton (Milton method) and SQ53-impreganted wipes (Wipe method), have been found to be effective at de-contaminating IC catheters. Milton is also known to be an acceptable method for catheter users with no increase in UTI or other unexpected adverse events. A randomised controlled trial (RCT) to test Milton as the cleaning method was halted when some GPs felt uncertain that they were indemnified for prescribing IC catheters ‘off’ label i.e. prescribing single use devices for re-use in the trial. We were advised by the MHRA to obtain a catheter CE marked for re-use in order to re-start the trial.
Cliny catheters (Create Medical) are CE-marked for re-use over 28 days and are potentially suitable for the trial. However, in the absence of clinical data and, as all our previous user testing was done with PVC catheters, we need to demonstrate that both methods clean silicone catheters as effectively as they do PVC ones and that trial participants would find Cliny catheters acceptable.
This feasibility study will establish the suitability of Cliny catheters for the Multicath RCT. Adult catheter users will clean and re-use Cliny catheters over 3 weeks returning cleaned catheters to the laboratory for microbiological analysis and providing feedback about their acceptability.REC name
West of Scotland REC 1
REC reference
18/WS/0160
Date of REC Opinion
1 Oct 2018
REC opinion
Further Information Favourable Opinion