Effectiveness of Preurodynamic With Posturodynamic Levofloxacin on the Incidence of UTI

Phase 1

Completed

• Conditions: Urinary Tract Infections
• Interventions: Drug: Pre-urodynamic Levofloxacin; Drug: Post-urodynamic Levofloxacin

• Registration Number: NCT05219877
• Lead Sponsor: Indonesia University

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-01-21
• Study First Posted: 2022-02-02
• Study Start: 2022-02-04
• Primary Completion: 2022-04-03
• Study Completion: 2022-04-13
• Results First Submitted: 2022-04-18
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-01
• Last Update Submitted: 2023-02-01
• Results First Posted: 2023-11-13
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-urodynamic Levofloxacin	Pre-urodynamic Levofloxacin	Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination
Post-urodynamic Levofloxacin	Post-urodynamic Levofloxacin	Levofloxacin 500 mg will be given for 3 days, once daily, post-urodynamic examination

Primary Outcome Measures

Name	Time	Method
Number of Participant With Urinary Tract Infection	4 days after urodynamic	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

Trial Locations

Locations (1)

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