Evaluation of "UroShield" Device Impact Upon Side Effects and Complications of Urinary Catheter Usage
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Primary Endpoint
- side effects and complications of urinary catheter usage
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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
- •without judgment.
Arms & Interventions
Patients receive inactive UroShield device
Patients receive inactive UroShield device
Intervention: Sham UroShield device (Device)
Patients receive active UroShield device
Patients receive active UroShield device
Intervention: UroShield device (Device)
Outcomes
Primary Outcomes
side effects and complications of urinary catheter usage
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported