Patients and methods
infection stones, renal or hepatic impairment, urinary diversions, megaloblastic, hypersensitivity
GROUP B, FOLATE DEFICIENCY ANEMIA, ACUTE ASTHMA, MEGALOBLASTIC, URINARY TRACT INFECTION (UTI), HYPERSENSITIVITY, COMPLICATIONS
This study was a prospective randomized clinical trial conducted on patients who underwent double J ureteral stent insertion, specifically using polyurethane double J stents. The stents were left in place for a duration of 2 weeks, and the study was conducted between January 2017 and January 2020.The sample size was determined using G*Power software (ver. 3.1.9.7; Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany). A significance level (α) of 0.05 was chosen, corresponding to a 5% chance of making a Type I error. Statistical power (1—beta, β) used for the study was set at 80%, indicating the probability of detecting a true effect if it exists.Eligible patients were randomized into four groups using a closed envelope method. Sequentially numbered closed opaque envelope used created by independent statistician and opened by pharmacist not in research team to ensure allocation concealment.Group A, the control group, consisted of 165 patients who received no antibiotics or mucolytics, while the stent was indwelling (only receive placebo). Group B consisted of 153 patients receiving only oral NAC (200 mg/day for children less than 12 years of age and 600 mg/day for adults) alone, while the stent was indwelling. Group C consisted of 162 patients receiving only oral co-trimoxazole (2 mg TMP/kg/day, a prophylactic dose), while the stent was indwelling. Group D consisted of 156 patients receiving both oral NAC and co-trimoxazole, while the stent was indwelling with doses identical to groups B and C. Randomization was performed at our clinic. The protocol of this study was approved by the faculty ethical committee no UR0011-2-180. Informed consent, to the procedure and possible complications, was obtained from all patients. We excluded pregnant and lactating women, children less than 3 months of age, and all patients undergoing long term double J ureteral stent insertion, preoperative urinary tract infection (UTI), patients with anatomical urological abnormalities, urinary diversions, infection stones hypersensitivity to sulfa drugs, megaloblastic or folate deficiency anemia, significant renal or hepatic impairment, hypersensitivity to NAC, diabetics and immunocompromised patients and patients with acute asthma.