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

Not Applicable

Withdrawn

• Conditions: Infectious
• Interventions: Device: UroShield device; Device: Sham UroShield device

• Registration Number: NCT02412891
• Lead Sponsor: HaEmek Medical Center, Israel

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-01
• Study First Submitted QC: 2015-04-08
• Study First Posted: 2015-04-09
• Study Start: 2015-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-28
• Last Update Posted: 2016-09-29
• Primary Completion: 2017-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients receive active UroShield device	UroShield device	Patients receive active UroShield device
Patients receive inactive UroShield device	Sham UroShield device	Patients receive inactive UroShield device

Primary Outcome Measures

Name	Time	Method
side effects and complications of urinary catheter usage	One Year	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