The Uroshield device is a commercially available device with two parts: a disposable actuator which attaches to the external portion of the catheter and a portable battery. The device sends out low-frequency ultrasound waves which run along the surfaces of the catheter. These acoustic waves prevent bacteria from adhering to the catheter and prevent the formation of biofilm. Our objective is to conduct a pilot study to determine if the UroShield device can reduce bacteriuria and catheter biofilm formation among neurogenic bladder patients with an indwelling catheter, as well as improve urinary quality of life and symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
6
The Uroshield device sends out low-frequency ultrasound waves which run along the surface of the catheter.
The sham Uroshield device is identical to the active machine, but it does not send out low-frequency ultrasound waves along the surface of the catheter.
St Josephs Hospital
London, Ontario, Canada
Bacteriuria
Proportion with bacteriuria \>10\^5 cfu at day 30
Time frame: 30 days
Neurogenic bladder symptom score (NBSS)
Validated symptom score that measures symptoms related to neurogenic bladder dysfunction and urinary quality of life. Total scale ranges from 0-74, and a lower number is considered a better outcome and represents lower symptom burden.
Time frame: 30 days
Patient subjective rating of amount of sediment/debris at the end of the 30 days
Time frame: 30 days
Total bacterial cell counts
Time frame: 30 days
Microbiome comparison of biofilms
Time frame: 30 days
Scanning electron microscopy of biofilms
Time frame: 30 days
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