Effectiveness of Preurodynamic With Posturodynamic Levofloxacin on the Incidence of UTI

Sponsor

Indonesia University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05219877

Collaborator

(none)

100

Enrollment

Location

Arms

43.9

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infections	Drug: Pre-urodynamic Levofloxacin Drug: Post-urodynamic Levofloxacin	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Prevention

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

Actual Study Start Date :

Apr 4, 2019

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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