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

March 24, 2009 updated by: Nanovibronix

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Recruiting
        • Shaare Zedek Medical Center
        • Contact:
          • Ofer Shenfeld, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
primary end points
Time Frame: up to 14 days
up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanovibronix

Collaborators

Shaare Zedek Medical Center

Investigators

  • Principal Investigator: Ofer Shenfeled, MD, Sharei Zedek

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Anticipated)

April 1, 2009

Study Completion (Anticipated)

June 1, 2009

Study Registration Dates

First Submitted

March 11, 2007

First Submitted That Met QC Criteria

March 12, 2007

First Posted (Estimate)

March 13, 2007

Study Record Updates

Last Update Posted (Estimate)

March 25, 2009

Last Update Submitted That Met QC Criteria

March 24, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US-71-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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