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

HaEmek Medical Center, Israel

Status: Withdrawn

Conditions: Infectious

Treatments: Device: Sham UroShield device; Device: UroShield device

Study type: Interventional

Funder types: Other

Identifiers

NCT02412891

0116-14-EMC

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Patients receive active UroShield device

Active Comparator group

Description:

Patients receive active UroShield device

Treatment:

Device: UroShield device

Patients receive inactive UroShield device

Sham Comparator group

Description:

Patients receive inactive UroShield device

Treatment:

Device: Sham UroShield device