The Use of the UroShield Device in Patients With Indwelling Urinary Catheters

Study Overview
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Brief Summary
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According to the Israeli Ministry of Health requirement, this study was designed to evaluate the efficacy of the UroShield system is patients that require urinary catheterization. This was designed to compare standard treatment (urinary catheter alone) with the UroShield treatment in occurrence of catheter associated Urinary Tract infection, pain, discomfort, Biofilm prevention and trauma.

Detailed Description
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This study is aimed at assessing the effectiveness of the NanoVibronix™ UroShield™ System in comparison to Urinary catheter alone in patients requiring urinary catheterization. Primary objectives To observe the effect of UroShield in reduction of patient's complaints relating to indwelling Urinary Catheters Pain Discomfort To observe the effect of UroShield in the reduction/prevention of Biofilm To observe the effect of UroShield on the occurrence of bacteriuria and/or UTI's on patients with Indwelling Urinary Catheters Safety Objective To assess the safety parameters of the UroShield system Secondary Objectives To observe the effect of UroShield in reduction of Foley Catheter related pain medication in patients with Indwelling Urinary Catheters To observe the effect of UroShield in reduction of antibiotic medication in patients with Indwelling Urinary Catheter To observe the effect of UroShield on the clogging of Urinary Catheter when used chronically and the need to replace the catheter To observe the effect of UroShield on the decrease of Tissue damage of patients with Indwelling Urinary Catheters by measuring cell count before and after removal of catheter

Official Title
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Catheter Associated Urinary Tract Infections

Conditions
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Urinary Tract Infection

Intervention / Treatment
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* Device: UroSshield


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized patients age 18 years or older Patients requiring or having catheterization for more than 24 hours Patient able, agrees and signs the Informed Consent Form Exclusion Criteria: Pregnant or breastfeeding women. Women of child bearing potential will perform a pregnancy test before inclusion into the study Presence of any clinically relevant known urinary tract infection Patient with condition who is not expected to survive the study period Known HIV positive Patient has any condition, which precludes compliance with study and/or device instructions. Patient is currently participating in another clinical study. Known allergy to latex

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Device: UroSshield<br>* Attachment of the UroShield device to the external part of the urinary catheter<br>|
| No Intervention: 2<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary end points |  | up to 14 days |