The Effect of Surface Acoustic Waves on the Prevention of Colonization in Longterm Indwelling Urinary Caatheters
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Other Indications, Urology, Urinary Tract Infections |
| Therapuetic Areas: | Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/25/2017 |
| Start Date: | January 1, 2017 |
| End Date: | March 1, 2018 |
The Effect of Surface Acoustic Waves on the Prevention of Bacterial Colonization in Longterm Indwelling Urinary Catheters
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.
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.
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.
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.
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.
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