Urological System Complication of Procedure, Urinary Tract Infections
Conditions
Keywords
urodynamic, urinary tract infections, fosfomycin, levofloxacin
Brief summary
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: * What is the difference between the effectiveness of administering a single dose of fosfomycin and levofloxacin prior to the procedure in terms of the incidence rate of urinary tract infection (UTI) post-urodynamic examination? * What is the incidence rate of UTI in the administration of single-dose fosfomycin and levofloxacin prior to the procedure on the incidence rate of UTI post-urodynamic examination? Participants fulfilling the inclusion criteria will be taken their history and vital signs and consume either fosfomycin or levofloxacin based on the randomisation prior to urodynamic procedure. Afterwards, participants will undergo urine analysis 4 days post urodynamic to evaluate if there's any urinary tract infection. If there is any bacteria present, the sample will be cultured to identify bacteria found in the urine.
Detailed description
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.
Interventions
DRUGFosfomycin 3000 MG
Fosfomycin 3 g single dosage 1 hour before the urodynamic examination
Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination
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 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.
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 * Allergy to fosfomycin * History of taking antibiotics in 1 month * Pregnant * Uncontrolled DM * Use of 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 |
|---|---|---|
| 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. | 4 days post-urodynamic procedure | 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. |
Countries
Indonesia
Participant flow
Recruitment details
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.
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 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 | 63 |
| 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 | 63 |
| Total | 126 |
Baseline characteristics
| Characteristic | Pre-urodynamic Fosfomycin | Pre-urodynamic Levofloxacin | Total |
|---|---|---|---|
| Age, Continuous | 53.99 years STANDARD_DEVIATION 19.08 | 42 years STANDARD_DEVIATION 17.17 | 52.2 years STANDARD_DEVIATION 18.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 63 Participants | 63 Participants | 126 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 | 27 Participants | 24 Participants | 51 Participants |
| Sex: Female, Male Male | 36 Participants | 39 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 63 |
| other Total, other adverse events | 3 / 63 | 2 / 63 |
| serious Total, serious adverse events | 0 / 63 | 0 / 63 |
Outcome results
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.
Time frame: 4 days post-urodynamic procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pre-urodynamic Fosfomycin | 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. | Diagnosed UTI | 12 Participants |
| Pre-urodynamic Fosfomycin | 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. | Symptomatic UTIs | 7 Participants |
| Pre-urodynamic Fosfomycin | 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. | Non UTIs | 44 Participants |
| Pre-urodynamic Levofloxacin | 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. | Diagnosed UTI | 14 Participants |
| Pre-urodynamic Levofloxacin | 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. | Symptomatic UTIs | 6 Participants |
| Pre-urodynamic Levofloxacin | 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. | Non UTIs | 43 Participants |
Comparison: This randomized controlled trial compared the incidence of UTI between two groups: patients receiving a single dose of 500 mg levofloxacin and patients receiving a single dose of 3 g fosfomycin one hour before a urodynamic study. The null hypothesis is that there is no significant difference in UTI incidence between the two groups. The power calculation was based on a sample size of 126 patients.p-value: 0.6695% CI: [0.4, 1.95]Chi-squared