Effectiveness of Preurodynamic With Posturodynamic Levofloxacin on the Incidence of UTI

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Drug: Pre-urodynamic Levofloxacin; Drug: Post-urodynamic Levofloxacin

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • RS Cipto Mangunkusumo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-urodynamic Levofloxacin; Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination	Drug: Pre-urodynamic Levofloxacin; Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination
Active Comparator: Post-urodynamic Levofloxacin; Levofloxacin 500 mg will be given for 3 days, once daily, post-urodynamic examination	Drug: Post-urodynamic Levofloxacin; Administering once daily Levofloxacin 500 mg for 3 days after urodynamic study

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Harrina Erlianti Rahardjo, Professor, Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2019
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 3, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Antibiotics; Urodynamics; Prophylaxis
• Additional Relevant MeSH Terms: Urologic Diseases; Infections; Urinary Tract Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Levofloxacin; Ofloxacin
• Other Study ID Numbers: 341/UN2.F1/ETIK/PPM.00.02/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: These are the study protocol used in this study
• IPD Sharing Time Frame: Immediately following publication. No end date
• IPD Sharing Access Criteria: Anyone who wishes to access the data
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No