The Effect of Ultrasound on Urinary Catheter Biofilms and Uropathogens
Research type
Research Study
Full title
To Evaluate the Effect of Surface Acoustic Wave Ultrasound on the Formation of Biofilm and the Presence of Bacterial Uropathogens on Urinary Catheters
IRAS ID
267053
Contact name
Sandra Wilks
Contact email
Sponsor organisation
University of Southampton
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
Healthcare associated infection (HCAI) affects over 6% of hospitalised patients in England and urinary tract infection (UTI) is the second most frequent cause, amounting to 17.2% of all HCAI (HPA, 2012). Indwelling urinary catheterisation (IUC) increases the risk of UTI, with an estimated 79.3% of UTI being attributable to urinary catheterisation. The long-term use of catheters has long been known to result in an almost permanent bacterial colonisation of urine with the likelihood of infection rising to 100% after 30 days following catheterisation.
This study aims to show the effect of the Nanovibronix UroShield™ CE-marked device on bacteria colonies in patients with indwelling urinary catheters to assess any changes to the catheter-associated microbiome in order to understand the impact of the UroShield™ on the biofilm community. The Nanovibronix UroShield™ is applied externally to the catheter and utilises low-frequency ultrasonic acoustic waves (Surface Acoustic Wave) which run longitudinally along both the inner and outer surfaces of the catheter. These surface acoustic waves prevent bacteria from docking and adhering to the catheter and subsequently prevent the formation of biofilm.
The study will involve collecting urine and catheter samples before, during and after use of the UroShield™ from a small sample of long-term catheter users. The microbial community structure will be studied and the data used to inform future clinical and laboratory testing, as well as product development. Techniques will include culture and direct microscopy analysis, as well as next generation sequencing to fully investigate the bacterial community present in the samples. All laboratory analyses will be undertaken within the microbiology laboratory at the University of Southampton. The study will last 9 months.
We will also seek to understand the experience of users of the device using a validated quality of life questionnaire and open-ended interviews.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
21/WM/0038
Date of REC Opinion
17 Mar 2021
REC opinion
Further Information Favourable Opinion