Viewing Study NCT05219877



Ignite Creation Date: 2024-05-06 @ 5:10 PM
Last Modification Date: 2024-10-26 @ 2:23 PM
Study NCT ID: NCT05219877
Status: COMPLETED
Last Update Posted: 2023-11-13
First Post: 2022-01-20

Brief Title: Effectiveness of Preurodynamic With Posturodynamic Levofloxacin on the Incidence of UTI
Sponsor: Indonesia University
Organization: Indonesia University

Study Overview

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
Status: COMPLETED
Status Verified Date: 2023-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 005

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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None