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IRCT20220213054009N1 IRCT 2022-04-18 Urology Research Center, Guilan University of Medical Sciences Comparison of prophylactic effect of single-dose and continuous-dose antibiotics on urinary tract infections (UTI) following transurethral lithotripsy (TUL) and stenting Comparison of prophylactic effect of single-dose and continuous-dose antibiotics on urinary tract infections (UTI) in patients with Double-J ureteral stent following transurethral lithotripsy (TUL) 2022-05-21 anticipated 90 Complete https://irct.ir/trial/61935 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Block randomization will done with blocks of size 4 with a ratio of 1 to 1 (as two groups A and B) via a online program named sealed envelop/randomization. One of the researcher (resident of urology) based on a table prepared from four random blocks, assigns patients to two groups: A (single dose) and B (continuous), by random replacement method. 2-3 Post-operative urinary tract infection. Intervention 1: Intervention group: receiving single dose intravenous ciprofloxacin (400 mg) before procedure. Intervention 2: Control group:receiving single dose intravenous ciprofloxacin (400 mg) before procedure + receiving 1 tablet of ciprofloxacin (500 mg) every 12 hours for 3 days and then one tablet of ciprofloxacin (250 mg) every night until stent removal. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to the possibility of prolonging the study and publication of the article, researchers will decide regarding the details of sharing the unidentifiable personal data of the participants after the end of the study and publication of the results in the form of an article.
public Bahador Heidari Bateni
Sardar-e-Jangal Ave.
Rasht Iran (Islamic Republic of) 41448-95655 +98 13 3352 5259 Bahador_hb@yahoo.com Rasht University of Medical Sciences scientific Reza Shahrokhi Damavand
Sardar-e-Jangal Ave.
Rasht Iran (Islamic Republic of) 41448-95655 +98 13 3352 5259 reza_sh_urg@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) Have a sterile urine culture before stent placement 18 years no limit Both Fever Use of antibiotics during the 2 weeks before the stenting operation Purulent discharge during TUL History or treatment of obstructive symptoms Chronic bacterial prostatitis Chronic pelvic pain syndrome Prostate cancer Chronic ureteral obstruction Obstruction due to malignancy Iatrogenic trauma Conditions prone to bleeding History of bladder cancer Recurrent urinary tract infections Irritable bladder syndrome History of mental or neurological disease Taking alpha-blockers and anticholinergics, painkillers, or other medications that may interfere with the symptoms of ureteral stent Pregnancy T83.51 Infection and inflammatory reaction due to urinary catheter Treatment - Drugs Treatment - Drugs Intervention group: receiving single dose intravenous ciprofloxacin (400 mg) before procedure Control group:receiving single dose intravenous ciprofloxacin (400 mg) before procedure + receiving 1 tablet of ciprofloxacin (500 mg) every 12 hours for 3 days and then one tablet of ciprofloxacin (250 mg) every night until stent removal Urinary tract infection after inserting the stent. Timepoint: The mean duration of stent indwelling time and before removing the stent. Method of measurement: Urine culture and urinalysis. Fever. Timepoint: During the stent indwelling time. Method of measurement: Interview and physical exam. Hematuria. Timepoint: During of stent indwelling time and before removing the stent. Method of measurement: Interview and questionnaire. Dysuria. Timepoint: During of stent indwelling time and before removing the stent. Method of measurement: Interview and questionnaire. Frequency. Timepoint: During of stent indwelling time and before removing the stent. Method of measurement: Interview and questionnaire. Nocturia. Timepoint: During of stent indwelling time and before removing the stent. Method of measurement: Interview and questionnaire. Flank pain. Timepoint: During of stent indwelling time and before removing the stent. Method of measurement: Interview and questionnaire. Side effects of contentious antibiotics. Timepoint: During of stent indwelling time. Method of measurement: Interview. Urology Research Center, Guilan University of Medical Sciences Approved 2022-01-26 Ethics Committee of Guilan University of Medical Sciences Sardar Jangal street Rasht Guilan Iran (Islamic Republic of)