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

Nanovibronix

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Urinary Tract Infection

Treatments: Device: UroSshield

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00446732

US-71-003

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

1

Active Comparator group

Treatment:

Device: UroSshield

2

No Intervention group