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Withdrawn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
About this trial
This is an interventional prevention trial for Infectious focused on measuring introduction of urinary catheter
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.
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
NCT ID
NCT02412891
First Posted
April 1, 2015
Last Updated
September 28, 2016
Sponsor
HaEmek Medical Center, Israel
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Withdrawn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
Learn more about this trial
Evaluation of "UroShield" Device Impact Upon Side Effects and Complications of Urinary Catheter Usage
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