RS Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, 10430, Indonesia
NCT Number: NCT05219877
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Jakarta Pusat, DKI Jakarta, 10430, Indonesia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination
Administering once daily Levofloxacin 500 mg for 3 days after urodynamic study
Time frame: 4 days after urodynamic
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
Indonesia University
Other
Comparison of the Effectiveness of Preurodynamic Single Dose of Levofloxacin With Posturodynamic Levofloxacin for Three Days on the Incidence of Urinary Tract Infections
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07627412
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Nanjing, Jiangsu, China
View Trial DetailsNCT06801405
Acute Kidney Injury, Antibiotic Prophylaxis
Jales, São Paulo, Brazil
View Trial DetailsNCT05319561
Common Infections, Female Urogenital Diseases
Cleveland, Ohio, United States
View Trial DetailsNCT07438184
Chronic Prostatitis (CP), Female Urogenital Diseases
Salamanca, Spain
View Trial Details