None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years or older 2. Hospitalized patients expected to require an indwelling urinary catheter (urethral or suprapubic catheter) for at least 3 days due to surgery, trauma, or neurological conditions 3. Patients who voluntarily provide written informed consent after receiving sufficient explanation of the study
Exclusion criteria
Exclusion criteria: 1. Patients with active urinary tract infection at screening or those who have not completed treatment 2. Patients with anatomical abnormalities such as urethral stricture or bladder stones 3. Pregnant or breastfeeding women, or those planning pregnancy 4. Patients with immunodeficiency or receiving immunosuppressive therapy 5. Patients with uncontrolled bleeding disorders 6. Any other condition that, in the investigator’s judgment, makes the patient unsuitable for participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of symptomatic catheter-associated urinary tract infection (CAUTI) and bacteriuria during the indwelling catheterization period | — |
Secondary
| Measure | Time frame |
|---|---|
| Degree of biofilm formation on retrieved catheters at the end of catheterization (surface coverage and density);Total duration of antibiotic use related to urinary tract symptoms;Incidence of catheter blockage or catheter replacement;Usability and satisfaction of the device ;Incidence of adverse events and device-related adverse effects | — |
Countries
Korea, Republic of
Contacts
Inje University Haeundae Paik Hospital