Baacterial Colonization, Urinary Tract Infections
Conditions
Keywords
Catheter, UTI's
Brief summary
This is a double blinded rct to evaluate the effect of the UroShield SAW transducer on preventing bacterial colonization in longterm indwelling catheters. The duration of the trial is 30 days. The investigator will be quantifying the number of bacterial colonies in the urinary catheter and in the bladder in both the treatment and control group.
Detailed description
This is a double blinded Randomized controoled trial of 30 days duration. The trial device is the Uroshield, SAW device which is an externally applied device attached to the external portion of the urinary catheter. Subjects will be randomized to a control group and the treatment group. The control group will receive standard of care for the care of indwelling urinary catheters, while being attached to a sham UroShield device. The treatment group will receive the same standard of care treatment but will be attached to an active UroShield SAW device. At baseline and again at 30 days, both the catheter and retained urine from the bladder will be evaluated for the number of live colonies. These numbers will be evaluated to see if there is a difference between the active and sham devices.
Interventions
DEVICEUroShield
The UroShield is an externally applied acoustic actuator which generates surface acoustic waves and transmits them along the length of the catheter. The device does not come in direct contact with the subjects.
Sponsors
Nanovibronix
Rosenblum, Jonathan I., DPM
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The UroShield device actuator will activate and create the hum, which is the only sign of its working even in the active device. While the active device will transmit Surface Acoustic Waves, the sham device will work but will not transmit any acoustic waves.
Intervention model description
This is a double blinded, randomized controlled trial. All involved will be blinded as to whether the supplied UroShield device is active or a sham.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Currently being treated with an indwelling urinary catheter for at least 30 days. * Ability to sign informed consent or have someone authorized to sign informed consent.
Exclusion criteria
* Currently being treated for an active Urinary Tract infection. * Previous treatment with Surface Acoustic Waves.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial Colonization | 30 days | Number of cultured colonies from both the Urinary Catheter and retained urine |
Countries
United States
Outcome results
None listed