Effectiveness of Preurodynamic With Posturodynamic Levofloxacin on the Incidence of UTI

Study Overview
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Brief Summary
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This study aims to compare the effectiveness of preoperative single dose of levofloxacin with postoperative levofloxacin for three days on the incidence of urinary tract infections (UTI) after urodynamic examination.

Detailed Description
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This study aims to compare the effectiveness of preoperative single dose of levofloxacin with postoperative levofloxacin for three days on the incidence of urinary tract infections (UTI) after urodynamic examination. This study uses a randomized single-blind trial design to compare the proportion of posturodynamic UTI in the group receiving preurodynamic single-dose levofloxacin with the group receiving three days - once daily of Levofloxacin posturodynamic. The target population is patients who undergo urodynamic examination at the RSUPN dr. Cipto Mangunkusumo, Siloam ASRI Hospital, and Persahabatan Hospital during the given time. of the study. The total sample size in this study was determined based on a two-proportion analytical sample calculation formula with type 1 error of 5% and type 2 error of 80%. On the fourth posturodynamic day, urinalysis and urine culture were performed to determine the diagnosis of UTI. To analyze the association between UTI and the treatment group, the chi-square test was used. Results were considered statistically significant if p < 0.05. The expected results are data on the comparison of the incidence of UTI after urodynamic examination in the group given a single dose of levofloxacin and levofloxacin for three days post-examination. The incidence of UTI in the group receiving a single preurodynamic dose of levofloxacin compared to the group receiving levofloxacin for three days posturodynamics.

Official Title
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Comparison of the Effectiveness of Preurodynamic Single Dose of Levofloxacin With Posturodynamic Levofloxacin for Three Days on the Incidence of Urinary Tract Infections

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Drug: Pre-urodynamic Levofloxacin
* Drug: Post-urodynamic Levofloxacin


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 History of taking antibiotics in 1 month • Pregnant Uncontrolled DM Use a 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 levofloxacin 500 mg single dose one hour before urodynamic examination and patients receiving levofloxacin 500 mg once daily for three days post-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 Levofloxacin<br>Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination | Drug: Pre-urodynamic Levofloxacin<br>* Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination<br>|
| Active Comparator: Post-urodynamic Levofloxacin<br>Levofloxacin 500 mg will be given for 3 days, once daily, post-urodynamic examination | Drug: Post-urodynamic Levofloxacin<br>* Administering once daily Levofloxacin 500 mg for 3 days after urodynamic study<br>|

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 : leukocyes > 5 / high power field, bacteria positive, nitrite positive, and/or positive leukocyte esterase | 4 days after urodynamic | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urodynamics, Antibiotics, Prophylaxis