Phase 2
Completed N=126
Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic for UTI Prevention
Urological System Complication of Procedure · Urinary Tract Infections
Source: ClinicalTrials.gov NCT06017479 ↗
Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: The Main Outcome Measure Was the Incidence of Urinary Tract Infection (UTI) Post-urodynamic Study (UDS), Diagnosed Through Urinalysis Indicating Leukocyturia, Positive Bacteria, Nitrite, and/or Leukocyte Esterase, Along With Clinical Symptoms. — 12; 14; 7; 6 Participants — p=0.660
Summary
The goal of this clinical trial is to compare the use of single dose fosfomycin and single dose levofloxacin as pre-urodynamic antibiotic prophylaxis for urinary tract infection prevention post-urodynamic in patients with lower urinary tract symptoms. The main question[s] it aims to answer are:
* What is the difference between the effectiveness of administering a single dose of fosfomycin and levofloxacin prior to the procedure in terms of the incidence rate of urinary tract infection (UTI) post-urodynamic examination?
* What is the incidence rate of UTI in the administration of single-dose fosfomycin and levofloxacin prior to the procedure on the incidence rate of UTI post-urodynamic examination? Participants fulfilling the inclusion criteria will be taken their history and vital signs and consume either fosfomycin or levofloxacin based on the randomisation prior to urodynamic procedure. Afterwards, participants will undergo urine analysis 4 days post urodynamic to evaluate if there's any urinary tract infection. If there is any bacteria present, the sample will be cultured to identify bacteria found in the urine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Main Outcome Measure Was the Incidence of Urinary Tract Infection (UTI) Post-urodynamic Study (UDS), Diagnosed Through Urinalysis Indicating Leukocyturia, Positive Bacteria, Nitrite, and/or Leukocyte Esterase, Along With Clinical Symptoms. |
12; 14; 7; 6; 44; 43 | 0.660 |
Eligibility Criteria
Inclusion Criteria
- Male/female patients > 18 years who have indications for urodynamics
- Willing to participate in research
Exclusion Criteria
- Allergy to levofloxacin
- Allergy to fosfomycin
- History of taking antibiotics in 1 month
- Pregnant
- Uncontrolled DM
- Use of urinary catheter
- Having a UTI before urodynamics, based on clinical symptoms and urine examination results
- Refuse to participate in research
Data sourced from ClinicalTrials.gov (NCT06017479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.