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

Urinary Tract Infection Clinical Trial

— CAUTI  

Official title:

Catheter Associated Urinary Tract Infections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00446732
• Other study ID #: US-71-003
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: March 11, 2007
• Last updated: March 24, 2009
• Start date: March 2007
• Est. completion date: June 2009

Study information

• Verified date: March 2009
• Source: Nanovibronix
• Contact: Ofer Shenfeld, MD
• Phone: 972-2-6555560
• Email: shenfeld[@]szmc.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Device:
• UroSshield
Attachment of the UroShield device to the external part of the urinary catheter

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Nanovibronix	Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary end points		up to 14 days	Yes