Clinical trial NCT05219877: Effectiveness of Preurodynamic With Posturodynamic Levofloxacin on the Incidence of UTI
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Urinary Tract Infections
Keywords: Urodynamics
Antibiotics
Prophylaxis
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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 \< 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participant With Urinary Tract Infection
timeFrame: 4 days after urodynamic
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: RS Cipto Mangunkusumo
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Harrina Erlianti Rahardjo, Professor
role: PRINCIPAL_INVESTIGATOR
References: