Infectious
Conditions
Keywords
introduction of urinary catheter
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.
Interventions
DEVICEUroShield device
The UroShield device is Consists of two units:Actuator and Driver.
DEVICESham UroShield device
Sponsors
HaEmek Medical Center, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed