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

Primary Purpose

Infectious

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
UroShield device
Sham UroShield device
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infectious focused on measuring introduction of urinary catheter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Patients receive active UroShield device

    Patients receive inactive UroShield device

    Arm Description

    Patients receive active UroShield device

    Patients receive inactive UroShield device

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    April 1, 2015
    Last Updated
    September 28, 2016
    Sponsor
    HaEmek Medical Center, Israel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02412891
    Brief Title
    Evaluation of "UroShield" Device Impact Upon Side Effects and Complications of Urinary Catheter Usage
    Official Title
    Evaluation of "UroShield" Device Impact Upon Side Effects and Complications of Urinary Catheter Usage
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Cancelled due to financial reasons
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    August 2017 (Anticipated)
    Study Completion Date
    August 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    HaEmek Medical Center, Israel

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infectious
    Keywords
    introduction of urinary catheter

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients receive active UroShield device
    Arm Type
    Active Comparator
    Arm Description
    Patients receive active UroShield device
    Arm Title
    Patients receive inactive UroShield device
    Arm Type
    Sham Comparator
    Arm Description
    Patients receive inactive UroShield device
    Intervention Type
    Device
    Intervention Name(s)
    UroShield device
    Intervention Description
    The UroShield device is Consists of two units:Actuator and Driver.
    Intervention Type
    Device
    Intervention Name(s)
    Sham UroShield device
    Primary Outcome Measure Information:
    Title
    side effects and complications of urinary catheter usage
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who need to insert a catheter urine as part of their treatment and rehabilitation at the orthopedic ward. Exclusion Criteria: Patients undergoing an invasive procedure in the past month some urinary tract, or the existence of a well-known structural pathology. patients with a urinary tract infection in the past year. Patients with a urinary tract infection when inserting a catheter. pregnant women. Patients under the age of 18. without judgment.

    12. IPD Sharing Statement

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

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