Effectiveness of Preurodynamic With Posturodynamic Levofloxacin on the Incidence of UTI
Primary Purpose
Urinary Tract Infections
Status
Enrolling by invitation
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
Pre-urodynamic Levofloxacin
Post-urodynamic Levofloxacin
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Tract Infections focused on measuring Urodynamics, Antibiotics, Prophylaxis
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
Sites / Locations
- RS Cipto Mangunkusumo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pre-urodynamic Levofloxacin
Post-urodynamic Levofloxacin
Arm Description
Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination
Levofloxacin 500 mg will be given for 3 days, once daily, post-urodynamic examination
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05219877
First Posted
January 20, 2022
Last Updated
February 3, 2022
Sponsor
Indonesia University
1. Study Identification
Unique Protocol Identification Number
NCT05219877
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 4, 2019 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
Urodynamics, Antibiotics, Prophylaxis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
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.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pre-urodynamic Levofloxacin
Arm Type
Experimental
Arm Description
Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination
Arm Title
Post-urodynamic Levofloxacin
Arm Type
Active Comparator
Arm Description
Levofloxacin 500 mg will be given for 3 days, once daily, post-urodynamic examination
Intervention Type
Drug
Intervention Name(s)
Pre-urodynamic Levofloxacin
Intervention Description
Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination
Intervention Type
Drug
Intervention Name(s)
Post-urodynamic Levofloxacin
Intervention Description
Administering once daily Levofloxacin 500 mg for 3 days after urodynamic study
Primary Outcome Measure Information:
Title
Number of participant with urinary tract Infection
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harrina Erlianti Rahardjo, Professor
Organizational Affiliation
Indonesia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
RS Cipto Mangunkusumo
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
These are the study protocol used in this study
IPD Sharing Time Frame
Immediately following publication. No end date
IPD Sharing Access Criteria
Anyone who wishes to access the data
Learn more about this trial
Effectiveness of Preurodynamic With Posturodynamic Levofloxacin on the Incidence of UTI
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