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

Launched by NANOVIBRONIX · Mar 12, 2007

Keywords

ClinConnect Summary

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 sa...

Gender

ALL

Eligibility 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