Urinary Tract Infections
Conditions
Keywords
Urodynamics, Antibiotics, Prophylaxis
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.
Interventions
DRUGPre-urodynamic Levofloxacin
Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination
DRUGPost-urodynamic Levofloxacin
Administering once daily Levofloxacin 500 mg for 3 days after urodynamic study
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Indonesia
Participant flow
Recruitment details
The data was collected using a consecutive sampling method until the required number of subjects is reached. The data source of this research is primary data taken from patients who have indications for urodynamic examination at dr. Cipto Mangunkusumo Hospital, Siloam Asri Hospital, and Persahabatan Hospital, Jakarta starting from February 4, 2022
Pre-assignment details
The inclusion criteria were any above 18-year-old who underwent UDS & were willing to participate in this study. Patients who had at least one of these exclusion criteria were excluded: allergy to levofloxacin, history of antibiotics consumption in 1 month prior to the study, pregnancy, uncontrolled and untreated diabetes mellitus, use of urinary catheter, UTI proved through urinalysis prior to the study, and refusal to participate.
Participants by arm
| Arm | Count |
|---|---|
| Pre-urodynamic Levofloxacin Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination
Pre-urodynamic Levofloxacin: Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination | 63 |
| Post-urodynamic Levofloxacin Levofloxacin 500 mg will be given for 3 days, once daily, post-urodynamic examination
Post-urodynamic Levofloxacin: Administering once daily Levofloxacin 500 mg for 3 days after urodynamic study | 63 |
| Total | 126 |
Baseline characteristics
| Characteristic | Post-urodynamic Levofloxacin | Total | Pre-urodynamic Levofloxacin |
|---|---|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 17 | 52.5 years STANDARD_DEVIATION 16.5 | 52 years STANDARD_DEVIATION 16 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 63 Participants | 126 Participants | 63 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 25 Participants | 55 Participants | 30 Participants |
| Sex: Female, Male Male | 38 Participants | 71 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 67 |
| other Total, other adverse events | 5 / 67 | 5 / 67 |
| serious Total, serious adverse events | 1 / 67 | 1 / 67 |
Outcome results
Primary
Number of Participant With Urinary Tract Infection
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
Time frame: 4 days after urodynamic
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-urodynamic Levofloxacin | Number of Participant With Urinary Tract Infection | 12 Participants |
| Post-urodynamic Levofloxacin | Number of Participant With Urinary Tract Infection | 13 Participants |