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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-urodynamic Levofloxacin | Experimental | Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination |
|
| Post-urodynamic Levofloxacin | Active Comparator | Levofloxacin 500 mg will be given for 3 days, once daily, post-urodynamic examination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-urodynamic Levofloxacin | Drug | Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 days after urodynamic |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harrina Erlianti Rahardjo, Professor | Indonesia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RS Cipto Mangunkusumo | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
These are the study protocol used in this study
Immediately following publication. No end date
Anyone who wishes to access the data
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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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Post-urodynamic Levofloxacin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 4 days after urodynamic |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematuria | Renal and urinary disorders | Non-systematic Assessment | Patient experienced hematuria two days after urodynamic study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nauseous | Gastrointestinal disorders | Non-systematic Assessment | Five patients reported that they experience nausea after consuming the antibiotics prescribed |
The limitation of the study is that many of the patients with UTIs refuse to undergo urine culture tests due to several reasons.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. dr. Harrina Erlianti | Department of Urology, Faculty of Medicine University of Indonesia - Cipto Mangunkusumo General Hospital | +62 816-825-226 | harrinaerlianti@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2022 | Feb 25, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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.
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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.
| Post-urodynamic Levofloxacin | Drug | Administering once daily Levofloxacin 500 mg for 3 days after urodynamic study |
|
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 0 |
| 67 |
| 1 |
| 67 |
| 5 |
| 67 |
| EG001 | 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 | 0 | 67 | 1 | 67 | 5 | 67 |
|
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |