Effectiveness of Preurodynamic With Posturodynamic Levofloxacin on the Incidence of UTI

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-04

Study Completion Date

2022-04-13

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.

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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.

Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

This study uses a single-blinded design because the outcome assessed in this study is urinalysis which is the objective outcome. The urinalysis evaluator is blinded to the drug regimen obtained by the research subjects.

Study Groups

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Pre-urodynamic Levofloxacin

Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination

Group Type EXPERIMENTAL

Pre-urodynamic Levofloxacin

Intervention Type DRUG

Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination

Post-urodynamic Levofloxacin

Levofloxacin 500 mg will be given for 3 days, once daily, post-urodynamic examination

Group Type ACTIVE_COMPARATOR

Post-urodynamic Levofloxacin

Intervention Type DRUG

Administering once daily Levofloxacin 500 mg for 3 days after urodynamic study

Interventions

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Pre-urodynamic Levofloxacin

Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination

Intervention Type DRUG

Post-urodynamic Levofloxacin

Administering once daily Levofloxacin 500 mg for 3 days after urodynamic study

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes