Urinary Tract Infection Clinical Trial
Official title:
Catheter Associated Urinary Tract Infections
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.
This study is aimed at assessing the effectiveness of the NanoVibronix™ UroShield™ System in
comparison to Urinary catheter alone in patients requiring urinary catheterization.
1. 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
2. Safety Objective To assess the safety parameters of the UroShield system
3. 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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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