The Use of the UroShield Device in Patients With Indwelling Urinary Catheters - Full Text View

Sponsored by:	Nanovibronix
Information provided by:	Nanovibronix
ClinicalTrials.gov Identifier:	NCT00446732

Purpose

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.

Condition	Intervention	Phase
Urinary Tract Infection	Device: Uroshield	Phase II Phase III

MedlinePlus related topics: Urinary Tract Infections

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Catheter Associated Urinary Tract Infections

Further study details as provided by Nanovibronix:

Primary Outcome Measures:

primary end points

Estimated Enrollment:	210
Study Start Date:	March 2007
Estimated Study Completion Date:	April 2007

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.

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446732

Contacts

Contact: Yehezkel Caine, MD

972-50-7428428

caine@herzoghospital.org

Sponsors and Collaborators

Nanovibronix

Investigators

Principal Investigator:

Ofer Shenfeled, MD

Sharei Zedek

More Information

Study ID Numbers:	US-71-003
Study First Received:	March 11, 2007
Last Updated:	March 12, 2007
ClinicalTrials.gov Identifier:	NCT00446732
Health Authority:	Israel: Ministry of Health

Study placed in the following topic categories:

Urologic Diseases
Urinary Tract Infections

Additional relevant MeSH terms:

Communicable Diseases
Infection

ClinicalTrials.gov processed this record on January 16, 2009