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The goal of this clinical trial is to compare the use of single dose fosfomycin and single dose levofloxacin as pre-urodynamic antibiotic prophylaxis for urinary tract infection prevention post-urodynamic in patients with lower urinary tract symptoms. The main question[s] it aims to answer are:
This study employs a single-blinded randomized clinical trial design to compare the proportion of UTI post-urodynamic examination between the group receiving single-dose levofloxacin pre-urodynamic examination and the group receiving levofloxacin post-urodynamic examination for three days. The target population consists of patients undergoing urodynamic examination at Dr. Cipto Mangunkusumo National Referral Hospital, Persahabatan National Hospital, and Siloam Asri Hospital. The total sample size required for this study is 126 patients. On the fourth day post-urodynamic examination, urinalysis and urine culture are performed to determine the diagnosis of UTI. To analyze the association between UTI and therapy groups, a chi-square test is used. Results are considered statistically significant if p < 0.05.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-urodynamic Fosfomycin | Experimental | Fosfomycin 3 g single dosage 1 hour before the urodynamic examination |
|
| Pre-urodynamic Levofloxacin | Experimental | Levofloxacin 500 miligrams single dosage 1 hour before the urodynamic examination |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fosfomycin 3000 MG | Drug | Fosfomycin 3 g single dosage 1 hour before the urodynamic examination |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Main Outcome Measure Was the Incidence of Urinary Tract Infection (UTI) Post-urodynamic Study (UDS), Diagnosed Through Urinalysis Indicating Leukocyturia, Positive Bacteria, Nitrite, and/or Leukocyte Esterase, Along With Clinical Symptoms. | Urinary tract infections (UTIs) were diagnosed using a combination of urinalysis and clinical symptoms. A positive result was determined by leukocyturia (more than five white blood cells per field of vision), presence of bacteria, nitrite, and/or leukocyte esterase. Patients diagnosed with UTI underwent urine cultures to identify bacterial presence and determine the specific pathogen. The study used descriptive statistics to compare UTI incidences between the two treatment groups (levofloxacin vs. fosfomycin), and statistical significance was assessed using chi-square analysis with a p-value of <0.05. | 4 days post-urodynamic procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harrina E Rahardjo, Professor | Indonesia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto Mangunkusumo Hospital | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27550876 | Background | Rahardjo HE, Tirtayasa PM, Afriansyah A, Parikesit D, Akbar MI. The Effectiveness of a Three Day Course Antibiotic Post-urodynamic Study in Preventing Lower Urinary Tract Infection. Acta Med Indones. 2016 Apr;48(2):84-90. | |
| 29305250 | Background | Chu CM, Lowder JL. Diagnosis and treatment of urinary tract infections across age groups. Am J Obstet Gynecol. 2018 Jul;219(1):40-51. doi: 10.1016/j.ajog.2017.12.231. Epub 2018 Jan 2. |
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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.
Data were collected using consecutive sampling until the required number of subjects was reached. The primary data source is from patients with indications for urodynamic examination at Dr. Cipto Mangunkusumo, Siloam Asri, and Persahabatan Hospitals, starting December 30, 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-urodynamic Fosfomycin | Fosfomycin 3 g single dosage 1 hour before the urodynamic examination Fosfomycin 3000 MG: Fosfomycin 3 g single dosage 1 hour before the urodynamic examination |
| FG001 | Pre-urodynamic Levofloxacin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Oct 27, 2022 |
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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 fosfomycin 3 grams and patients receiving levofloxacin 500 miligrams single dose one hour before 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.
| Levofloxacin 500mg | Drug | Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination |
|
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| 32823650 | Background | Fajfr M, Balik M, Cermakova E, Bostik P. Effective Treatment for Uncomplicated Urinary Tract Infections with Oral Fosfomycin, Single Center Four Year Retrospective Study. Antibiotics (Basel). 2020 Aug 13;9(8):511. doi: 10.3390/antibiotics9080511. |
| 40660169 | Derived | Rahardjo HE, Widia F, Wijaya C, Leonardo K, Tanjung A, Arfiananda MH, Fitriani FN, Siregar RAF, Afriansyah A. Comparison of the effectiveness of single-dose levofloxacin with single-dose fosfomycin pre-urodynamic study related to the incidence of urinary tract infection: a randomized controlled trial. BMC Urol. 2025 Jul 14;25(1):172. doi: 10.1186/s12894-025-01839-y. |
Levofloxacin 500 miligrams single dosage 1 hour before the urodynamic examination
Levofloxacin 500mg: Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination
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| NOT COMPLETED |
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Besides the required samples are 126 samples to complete the study. There are 59 samples that didn't meet the inclusion criteria of the study, which are because of there are 8 samples who refuse to participate, 14 samples that are under 18 years old, 7 samples that have history of antibiotics consumption in 1 month prior to the study, 19 samples that are UTI proved through urinalysis, 11 samples that use of urinary catheter prior to the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-urodynamic Fosfomycin | Fosfomycin 3 g single dosage 1 hour before the urodynamic examination Fosfomycin 3000 MG: Fosfomycin 3 g single dosage 1 hour before the urodynamic examination |
| BG001 | Pre-urodynamic Levofloxacin | Levofloxacin 500 miligrams single dosage 1 hour before the urodynamic examination Levofloxacin 500mg: Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | The Main Outcome Measure Was the Incidence of Urinary Tract Infection (UTI) Post-urodynamic Study (UDS), Diagnosed Through Urinalysis Indicating Leukocyturia, Positive Bacteria, Nitrite, and/or Leukocyte Esterase, Along With Clinical Symptoms. | Urinary tract infections (UTIs) were diagnosed using a combination of urinalysis and clinical symptoms. A positive result was determined by leukocyturia (more than five white blood cells per field of vision), presence of bacteria, nitrite, and/or leukocyte esterase. Patients diagnosed with UTI underwent urine cultures to identify bacterial presence and determine the specific pathogen. The study used descriptive statistics to compare UTI incidences between the two treatment groups (levofloxacin vs. fosfomycin), and statistical significance was assessed using chi-square analysis with a p-value of <0.05. | Posted | Count of Participants | Participants | 4 days post-urodynamic procedure |
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After four days of Single Dose Fosfomycin and Single Dose Levofloxacin administration, patients were being assessed for their clinical conditions, such as symptoms related to UTIs, and also adverse events related to Levofloxacin, Fosfomycin administration, and UDS
The adverse events were collected through direct interviews with the patients four days after the procedure.
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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 Fosfomycin | Fosfomycin 3 g single dosage 1 hour before the urodynamic examination Fosfomycin 3000 MG: Fosfomycin 3 g single dosage 1 hour before the urodynamic examination | 0 | 63 | 0 | 63 | 3 | 63 |
| EG001 | Pre-urodynamic Levofloxacin | Levofloxacin 500 miligrams single dosage 1 hour before the urodynamic examination Levofloxacin 500mg: Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination | 0 | 63 | 0 | 63 | 2 | 63 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nauseous | Gastrointestinal disorders | Systematic Assessment | Five patients reported that they experience nausea after consuming the antibiotics prescribed |
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The limitation of the study is that many of the patients with UTIs refuse to undergo urine culture tests due to several reasons.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. dr. Harrina Erlianti Rahardjo, Sp.U(K), PhD | Department of Urology, Faculty of Medicine University of Indonesia - Cipto Mangunkusumo General Hospital | +62 816-825-226 | harrinaerlianti@gmail.com |
| Apr 23, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D005578 | Fosfomycin |
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Non UTIs |
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| Other |
"Chi-square test" as the study used chi-square analysis to compare the incidence of UTIs between the groups (p = 0.660) For this non-inferiority analysis, the study demonstrated that the odds ratio (OR) between the two groups was 0.8 (95% CI: 0.4-1.95), indicating no significant difference. Further details are provided in the study's discussion section. |
A chi-square test was performed to compare the incidence of UTIs between the two groups: patients receiving a single dose of 500 mg levofloxacin and those receiving a single dose of 3 g fosfomycin, both administered one hour before the urodynamic study (UDS). The result showed no statistically significant difference between the two groups (p = 0.660). An odds ratio was also calculated (OR = 0.8, 95% CI: 0.4-1.95), indicating a slightly lower likelihood of UTI in the fosfomycin group, but the difference was not significant. |