NCT00446732

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

Catheter Associated Urinary Tract Infections

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Nanovibronix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Urinary Tract Infection

Interventions

Type	Name	Description
DEVICE	UroSshield	Attachment of the UroShield device to the external part of the urinary catheter

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-04-01
• Completion: 2009-06-01
• First posted: 2007-03-13
• Last updated: 2009-03-25

Locations

1 site across 1 country: Israel