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 addition since antibiotic treatment is less effective in treating biofilm, higher doses are needed thus increasing the risk of antibiotic resistant.
In this study, we have tested the potential of the UroShield ultrasound device in replacing antibiotic therapy in subjects requiring urinary catheter following radical prostatectomy.
This is a prospective, two arms randomized study.
Group 1 – Post operative single dose of Ceftriaxon 2g + Active UroShield
Group 2 – Post operative dose of Ceftriaxon 2g on Day 1-3 + trimetoprim 2x200mg per day until the end of the study.
40 subjects were recruited for the study (20 subject in each group)
The overall plan for all subjects consists of the following elements:
This study is aimed to assess the safety and effectiveness of the UroShield device in replacing antibiotic therapy for preventing Bacteriuria/UTI in subjects following radical prostatectomy
The average age was 66.7 and 60.7 for group 1 and group 2, respectively. The average catheter days was 8.4 days (low – 7, high – 12) and 8.3 (low -7, high – 10) for group 1 and group 2, respectively
In group 1 there was one (1) case of bacteriuria at the end of the study (bacteriuria rate = 5%) while in group two 2 there were four (4) cases of bacteriuria at the end of the study (bacteriuria rate = 20%)
The results demonstrated that UroShield is superior to daily antibiotic treatment in preventing bacteriuria thus reducing UTI rate following radical prostatectomy. These results demonstrate a new approach to reducing antibiotic treatment, lessen the risk for bacterial resistance, and improve patient outcome by using UroShield ultrasound device.