Effectiveness of Preurodynamic With Posturodynamic Levofloxacin on the Incidence of UTI

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05219877
• Other study ID #: 341/UN2.F1/ETIK/PPM.00.02/2021
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 4, 2022
• Est. completion date: April 13, 2022

Study information

• Verified date: February 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: April 13, 2022
• Est. primary completion date: April 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Urinary Tract Infections

Intervention

Drug:
• Pre-urodynamic Levofloxacin
Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination
• Post-urodynamic Levofloxacin
Administering once daily Levofloxacin 500 mg for 3 days after urodynamic study

Locations

Country	Name	City	State
Indonesia	RS Cipto Mangunkusumo	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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