NCT02412891

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 29, 2016

Status Verified

September 1, 2016

Enrollment Period

2 years

First QC Date

April 1, 2015

Last Update Submit

September 28, 2016

Conditions

Infectious

Keywords

introduction of urinary catheter

Outcome Measures

Primary Outcomes (1)

  • 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

    One Year

Study Arms (2)

Patients receive active UroShield device

ACTIVE COMPARATOR

Patients receive active UroShield device

Device: UroShield device

Patients receive inactive UroShield device

SHAM COMPARATOR

Patients receive inactive UroShield device

Device: Sham UroShield device

Interventions

UroShield deviceDEVICE

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

Patients receive active UroShield device
Sham UroShield deviceDEVICE
Patients receive inactive UroShield device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who need to insert a catheter urine as part of their treatment and rehabilitation at the orthopedic ward.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2015

First Posted

April 9, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

September 29, 2016

Record last verified: 2016-09