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

Study Overview
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Brief Summary
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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
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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 is patients undergoing urodynamic examination at Dr. Cipto Mangunkusumo National Referral Hospital, Persahabatan National Hospital, and Siloam Asri Hospital. The total sample size in this study is 100 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.

Official Title
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Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic Prophylaxis for Urinary Tract Infection Prevention in Post-Urodynamic Examination

Conditions
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Urological System Complication of Procedure, Urinary Tract Infections

Intervention / Treatment
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* Drug: Fosfomycin 3000 MG
* Drug: Levofloxacin 500mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is an experimental study with a single-blinded randomized clinical trial design to compare the proportion of UTIs in a group of patients receiving fosfomycin 3 grams and patients receiving levofloxacin 500 miligrams single dose one hour before urodynamic examination. To determine the sample treatment group, blocked randomization technique is used in this study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-urodynamic Fosfomycin<br>Fosfomycin 3 g single dosage 1 hour before the urodynamic examination | Drug: Fosfomycin 3000 MG<br>* Fosfomycin 3 g single dosage 1 hour before the urodynamic examination<br>* Other names: Monuril;|
| Experimental: Pre-urodynamic Levofloxacin<br>Levofloxacin 500 miligrams single dosage 1 hour before the urodynamic examination | Drug: Levofloxacin 500mg<br>* Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination<br>* Other names: Levaquin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participant With Urinary Tract Infection | Urinary tract infection is defined based on the result of urinalysis in which one of the following condition present : leukocytes > 5 / high power field, bacteria positive, nitrite positive, and/or positive leukocyte esterase | 4 days post-urodynamic procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urodynamic, urinary tract infections, fosfomycin, levofloxacin