The Effect of Surface Acoustic Waves on the Prevention of Colonization in Longterm Indwelling Urinary Caatheters

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Surface Acoustic Waves on the Prevention of Bacterial Colonization in Longterm Indwelling Urinary Catheters

Conditions
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Baacterial Colonization, Urinary Tract Infections

Intervention / Treatment
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* Device: UroShield


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control Group<br>At catheter replacement subjects will have a sham UroShield device attached to the external portion of the catheter and have it activated for 30 days. Standard of care for the upkeep and cleanliness of the catheter will be adhered to. At both the baseline and at the conclusion of 30 days, the distal end of the catheter will be collected as well as a sample of retained urine from the bladder and these samples will be evaluated for bacterial colonization. | Device: UroShield<br>* 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.<br>* Other names: Surface Acoustic Wave Actuator;|
| Active Comparator: Treatment Group<br>At catheter replacement subjects will have an active UroShield device attached to the external portion of the catheter and have it activated for 30 days. Standard of care for the upkeep and cleanliness of the catheter will be adhered to. At both the baseline and at the conclusion of 30 days, the distal end of the catheter will be collected as well as a sample of retained urine from the bladder and these samples will be evaluated for bacterial colonization. | Device: UroShield<br>* 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.<br>* Other names: Surface Acoustic Wave Actuator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial Colonization | Number of cultured colonies from both the Urinary Catheter and retained urine | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheter, UTI's