Evaluation of "UroShield" Device Impact Upon Side Effects and Complications of Urinary Catheter Usage

HaEmek Medical Center, Israel

Overview

Evaluation of "UroShield" device impact upon side effects and complications of urinary catheter usage. The use of urinary catheters is a common medical practice in the perioperative setting. As such, it exposes the patient to certain comorbidities, including urinary tract infections. The infectious process is known to begin with a development of a biofilm on the catheter's surface. This fact makes it an attractive target for UTI prevention technology. Ultrasound waves were shown to reduce biofilm buildup in-vitro. We plan to determine the efficacy of this method in vivo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Conditions

Infectious

Interventions

UroShield deviceDEVICE

The UroShield device is Consists of two units:Actuator and Driver.

Sham UroShield deviceDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who need to insert a catheter urine as part of their treatment and rehabilitation at the orthopedic ward. Exclusion Criteria: 1. Patients undergoing an invasive procedure in the past month some urinary tract, or the existence of a well-known structural pathology. 2. patients with a urinary tract infection in the past year. 3. Patients with a urinary tract infection when inserting a catheter. 4. pregnant women. 5. Patients under the age of 18. 6. without judgment.

Outcomes

Primary Outcomes

side effects and complications of urinary catheter usage

the measure is a composite of :complaints related to the uro-genital system, the results of blood and urine tests, monitoring fever, blood pressure and pulse

Time frame: One Year

Data from ClinicalTrials.gov

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