The safety and efficacy of a urinary catheter designed to prevent catheter associated urinary infections is studied.
This study is an open randomized controlled trial of 4 weeks duration. The intervention is a novel urinary catheter with an electromagnetic therapy to prevent catheter associated infections. The catheter is used in patients which require longterm urinary catheterization over at least 1 month. The endpoint is bacteriological exam and the laboratory is blinded to the therapy status. Weekly urinary cultures are drawn and a sonication culture of the catheter tip is performed to detect and characterize the biofilm. A colonization rate of \>95% is anticipated in the control arm. Therefore a 50% reduction in colonization can be detected with 54 patients, a 90% reduction in colonization can be detected with 20 patients with a power of 0.9.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
54
The study catheter is inserted over the urethra in the bladder as a foley catheter. The study foley catheter delivers electromagnetic therapy.
The control arm catheter is inserted over the urethra in the bladder. The control catheter is a Mona-Therm catheter from Covidien.
University Hospital Balgrist
Zurich, Canton of Zurich, Switzerland
RECRUITINGBacterial biofilm on catheter, assessed by ultrasonic culture of catheter tip removed at the end of the study.
Time frame: 4 weeks
Significant bacteriuria assessed by weekly bacterial cultures.
Time frame: every week during 4 weeks
Clinically symptomatic catheter associated lower urinary infections.
Time frame: 4 weeks
occurence of adverse events
safety endpoint
Time frame: within 4 weeks
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