Trial Outcomes & Findings for Effectiveness of Preurodynamic With Posturodynamic Levofloxacin on the Incidence of UTI (NCT NCT05219877)
NCT ID: NCT05219877
Last Updated: 2023-11-13
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
134 participants
Primary outcome timeframe
4 days after urodynamic
Results posted on
2023-11-13
Participant Flow
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
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
67
|
|
Overall Study
COMPLETED
|
63
|
63
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Preurodynamic With Posturodynamic Levofloxacin on the Incidence of UTI
Baseline characteristics by cohort
| Measure |
Pre-urodynamic Levofloxacin
n=63 Participants
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
|
Post-urodynamic Levofloxacin
n=63 Participants
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
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
63 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 16 • n=5 Participants
|
53 years
STANDARD_DEVIATION 17 • n=7 Participants
|
52.5 years
STANDARD_DEVIATION 16.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 days after urodynamicUrinary 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
Outcome measures
| Measure |
Pre-urodynamic Levofloxacin
n=63 Participants
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
|
Post-urodynamic Levofloxacin
n=63 Participants
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
|
|---|---|---|
|
Number of Participant With Urinary Tract Infection
|
12 Participants
|
13 Participants
|
Adverse Events
Pre-urodynamic Levofloxacin
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Post-urodynamic Levofloxacin
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pre-urodynamic Levofloxacin
n=67 participants at risk
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
|
Post-urodynamic Levofloxacin
n=67 participants at risk
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
|
|---|---|---|
|
Renal and urinary disorders
Hematuria
|
1.5%
1/67 • Number of events 1 • After four days of Levofloxacin administration, patients were being assessed for their clinical conditions, such as symptoms related to UTIs, and also adverse events related to Levofloxacin administration and UDS
The adverse events were collected through direct interviews with the patients four days after the procedure. However, one patient reported to the the investigator two days after the procedure due to hematuria.
|
1.5%
1/67 • Number of events 1 • After four days of Levofloxacin administration, patients were being assessed for their clinical conditions, such as symptoms related to UTIs, and also adverse events related to Levofloxacin administration and UDS
The adverse events were collected through direct interviews with the patients four days after the procedure. However, one patient reported to the the investigator two days after the procedure due to hematuria.
|
Other adverse events
| Measure |
Pre-urodynamic Levofloxacin
n=67 participants at risk
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
|
Post-urodynamic Levofloxacin
n=67 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Nauseous
|
7.5%
5/67 • Number of events 5 • After four days of Levofloxacin administration, patients were being assessed for their clinical conditions, such as symptoms related to UTIs, and also adverse events related to Levofloxacin administration and UDS
The adverse events were collected through direct interviews with the patients four days after the procedure. However, one patient reported to the the investigator two days after the procedure due to hematuria.
|
7.5%
5/67 • Number of events 5 • After four days of Levofloxacin administration, patients were being assessed for their clinical conditions, such as symptoms related to UTIs, and also adverse events related to Levofloxacin administration and UDS
The adverse events were collected through direct interviews with the patients four days after the procedure. However, one patient reported to the the investigator two days after the procedure due to hematuria.
|
Additional Information
Prof. dr. Harrina Erlianti
Department of Urology, Faculty of Medicine University of Indonesia - Cipto Mangunkusumo General Hospital
Phone: +62 816-825-226
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place