Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic for UTI Prevention

Phase 1

Completed

• Conditions: Urinary Tract Infections; Urological System Complication of Procedure
• Interventions: Drug: Fosfomycin 3000 MG; Drug: Levofloxacin 500mg

• Registration Number: NCT06017479
• Lead Sponsor: Indonesia University

Brief 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.

Detailed Description

This study employs a single-blinded randomized clinical trial design to compare the proportion of UTI post-urodynamic examination between the group receiving single-dose levofloxacin pre-urodynamic examination and the group receiving levofloxacin post-urodynamic examination for three days. The target population consists of patients undergoing urodynamic examination at Dr. Cipto Mangunkusumo National Referral Hospital, Persahabatan National Hospital, and Siloam Asri Hospital. The total sample size required for this study is 126 patients. On the fourth day post-urodynamic examination, urinalysis and urine culture are performed to determine the diagnosis of UTI. To analyze the association between UTI and therapy groups, a chi-square test is used. Results are considered statistically significant if p \< 0.05.

Study Timeline

• Study Start: 2022-12-30
• Study First Submitted: 2023-08-24
• Study First Submitted QC: 2023-08-24
• Study First Posted: 2023-08-30
• Primary Completion: 2024-03-25
• Study Completion: 2024-03-25
• Results First Submitted: 2024-04-23
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-02
• Last Update Submitted: 2024-10-02
• Results First Posted: 2024-10-09
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-urodynamic Fosfomycin	Fosfomycin 3000 MG	Fosfomycin 3 g single dosage 1 hour before the urodynamic examination
Pre-urodynamic Levofloxacin	Levofloxacin 500mg	Levofloxacin 500 miligrams single dosage 1 hour before the urodynamic examination

Primary Outcome Measures

Name	Time	Method
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.	4 days post-urodynamic procedure	Urinary tract infections (UTIs) were diagnosed using a combination of urinalysis and clinical symptoms. A positive result was determined by leukocyturia (more than five white blood cells per field of vision), presence of bacteria, nitrite, and/or leukocyte esterase. Patients diagnosed with UTI underwent urine cultures to identify bacterial presence and determine the specific pathogen. The study used descriptive statistics to compare UTI incidences between the two treatment groups (levofloxacin vs. fosfomycin), and statistical significance was assessed using chi-square analysis with a p-value of \<0.05.

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia