Effectiveness of Preurodynamic With Posturodynamic Levofloxacin on the Incidence of UTI

University of Indonesia (UI)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Urinary Tract Infections

Treatments: Drug: Post-urodynamic Levofloxacin; Drug: Pre-urodynamic Levofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT05219877

341/UN2.F1/ETIK/PPM.00.02/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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134 participants in 2 patient groups

Pre-urodynamic Levofloxacin

Experimental group

Description:

Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination

Treatment:

Drug: Pre-urodynamic Levofloxacin

Post-urodynamic Levofloxacin

Active Comparator group

Description:

Levofloxacin 500 mg will be given for 3 days, once daily, post-urodynamic examination

Treatment:

Drug: Post-urodynamic Levofloxacin