BIOFILM PREVENTION BY SURFACE ACOUSTIC WAVES: A NEW APPROACH TO URINARY TRACT INFECTIONS
Urinary tract infections (UTI) account for approx. 40% of all nosocomial infections. The urinary catheter is a primary source for such infections due to the colonization of bacteria on the catheter surface and the creation of biofilm.
In this study, we have tested the potential of the UroShield low frequency ultrasound device in preventing biofilm creation in catheters in subjects requiring urinary catheterization. The UroShield device creates low intensity waves on the inner and outer surfaces of the indwelling urinary catheter to prevent bacterial adhesion, hence prevent biofilm formation.
A randomized, sham controlled double blinded safety trial. Independent evaluation of the catheters for biofilm was performed.
A total of 22 patients were recruited to the study in which 11 patients received UroShield (NanoVibronix Ltd., Nesher, Israel) and 11 patients received a sham device post-urological surgery.
The overall plan for all subjects consists of the following elements:
- Subjects were assessed for their eligibility to participate in the study according to the inclusions/exclusions criteria and signed a written informed consent according to Declaration of Helsinki and local regulations
- Randomization procedure was performed in order to determined the subject’s study group
- Following the surgical procedure, the UroShield was attached to the urinary catheter and activated
- Catheter removal, fixation and biofilm analysis in Scanning Electron Microscope (SEM)
This study is aimed to assess the safety, tolerability and biofilm formation in subjects that requires urinary catheter
The clinical diagnosis of the subjects is described in table 1. Average usage of the UroShield was approx. 9 days for both groups. The UroShield proved to be safe and well tolerated with no significant difference in reported adverse events between the two groups.
SEM analysis of the catheters revealed that there was no biofilm formation in the group of patients which were treated with UroShield, compared to the sham-group in which 7 catheters had biofilm (table 2). In addition, the treatment group had statistically significant less consumption of analgesics during the study period, indicating a reduction in pain levels during the study.
Biofilm formation can be prevented- or delayed- by applying low intensity nanowaves along the surfaces of an indwelling catheter. This approach opens new options for pharmacological prevention of urinary tract infections.