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Completed

NCT Number: NCT05219877

Effectiveness of Preurodynamic With Posturodynamic Levofloxacin on the Incidence of UTI

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

RS Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pre-urodynamic Levofloxacin

Drug

Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination

Post-urodynamic Levofloxacin

Drug

Administering once daily Levofloxacin 500 mg for 3 days after urodynamic study

Primary outcomes

  1. Number of Participant With Urinary Tract Infection

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 2, 2022
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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