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IRCT20200704047998N1 IRCT 2020-11-17 Iran University of Medical Sciences The effect of tamsulosin and hydrochlorothiazide on stone excretion THSS The effect of tamsulosin, hydrochlorothiazide or concomitant use of both in increasing the risk of stone excretion after ESWL Stones smaller than 2 cm Upper ureter 2019-05-22 anticipated 240 Complete https://irct.ir/trial/49378 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were grouped according to Balanced Block Randomization method in four groups A and B, C and D. All four drugs were in boxes A, B, C and D, and only the doctor in charge of the project (supervisor) was aware of the drug content of each group. Then, for use for each patient, numbering was done by the supervisor and what was written in the office. For example, patient number 1 of drug A and patient number 2 of drug B or vice versa, how to blind it is described below. The main idea of ​​block randomization was to divide patients into M blocks of size 2N, so that in each block N patients were assigned A and N patients were assigned to B. The block was then randomly selected. This method ensures equal treatment allocation per block provided the block is fully utilized. For example: two treatments A, B and block size 2 × 2 = 4 Assignment of treatment is possible within each block (1) AABB (2) BBAA, (3) ABAB, (4) BABA, (5) ABBA, (6) BAAB The size of the block, depending on the number of treatments, should be short enough to prevent imbalance, and large enough to prevent guessing treatment allocation in each group during the study. The block size should be at least twice the number of treatment nodes. The size of the block was stated in the study so that researchers would be blind to it. If the blocks were expressed, the treatment series in each block could be guessed. For example, in block 2N = 4, A A B must be B and in A A as B B can be deduced. This could lead to (selection bias). The solution to prevent this error was to: (1) not reveal the block mechanism. (2). Use random block size, Blinding description: Patients are treated with pre-determined medication packages by the study supervisor (supervisor). The drug packages are quite similar in shape and the patient and the project manager are not aware of the contents of the packages. Forms are completed by the project manager and his assistant who are unaware of the contents of the packages; In the data analysis stage, the analysis will be performed by the project consultant and the project manager, who are not aware of the contents of the drug packages, and only the group of patients (group 1 or 2 or 3 or 4) will be identified for data analysis; Therefore, the study is three Socors and from the stage of the patient's entry into the study to the study, data collection and information analysis, the contents of the drug group are not clear. 3 Renal stone. Intervention 1: The first group was treated with tamsulosin (0.4 mg / day, manufactured by Daru Pakhsh Company, Tehran, Iran). Patients were followed up for 3 months and asked about stone removal, number of renal colic episodes, pain intensity based on VAS and the amount of analgesia used during 3 months after ESWL. Patients also underwent ultrasound and if the stone remaining in the follow-up was less than 4 mm, the removal of the stone was considered successful. Intervention 2: The second group was treated with hydrochlorothiazide (25 mg twice daily, made by Caspian Drug Company, Rasht, Iran). Patients were followed up for 3 months and asked about stone removal, number of renal colic episodes, pain intensity based on VAS and the amount of analgesia used during 3 months after ESWL. Patients also underwent ultrasound and if the stone remaining in the follow-up was less than 4 mm, the removal of the stone was considered successful. Intervention 3: Intervention group: , the third group was treated with tamsulosin (0.4 mg / day) and hydrochlorothiazide (25 mg twice daily) and patients were followed for 3 months. Regarding stone removal, the number of renal colic episodes, Pain intensity was assessed based on VAS and the amount of analgesia used during 3 months after ESWL by asking patients. Patients also underwent ultrasound and if the stone remaining in the follow-up was less than 4 mm, the removal of the stone was considered successful. Intervention 4: Control group: The fourth group received only housing as a control group along with placebo. It should be noted that all study groups received analgesia in case of pain. 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 I need to consult
public Behnam Salehi
Vali Asr Ave
Tehran Iran (Islamic Republic of) 1699714713 +98 21 81161 Dr.behnam.salehi68@gmail.com Iran University of Medical Sciences scientific Behnam Salehi
Vali Asr Ave
Tehran Iran (Islamic Republic of) 1699714713 +98 21 81161 dr.behnam.salehi68@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) All patients with ureteral stones below 2 cm are placed under a crusher 1 year no limit Both Stone above 2 cm upper ureter Severe and moderate hydronephrosis N20.1 Calculus of ureter Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo The first group was treated with tamsulosin (0.4 mg / day, manufactured by Daru Pakhsh Company, Tehran, Iran). Patients were followed up for 3 months and asked about stone removal, number of renal colic episodes, pain intensity based on VAS and the amount of analgesia used during 3 months after ESWL. Patients also underwent ultrasound and if the stone remaining in the follow-up was less than 4 mm, the removal of the stone was considered successful. The second group was treated with hydrochlorothiazide (25 mg twice daily, made by Caspian Drug Company, Rasht, Iran). Patients were followed up for 3 months and asked about stone removal, number of renal colic episodes, pain intensity based on VAS and the amount of analgesia used during 3 months after ESWL. Patients also underwent ultrasound and if the stone remaining in the follow-up was less than 4 mm, the removal of the stone was considered successful. Intervention group: , the third group was treated with tamsulosin (0.4 mg / day) and hydrochlorothiazide (25 mg twice daily) and patients were followed for 3 months. Regarding stone removal, the number of renal colic episodes, Pain intensity was assessed based on VAS and the amount of analgesia used during 3 months after ESWL by asking patients. Patients also underwent ultrasound and if the stone remaining in the follow-up was less than 4 mm, the removal of the stone was considered successful. Control group: The fourth group received only housing as a control group along with placebo. It should be noted that all study groups received analgesia in case of pain. Stone passage. Timepoint: Immediately .A week. One Month . three months. Method of measurement: Patient history for stone removal. Iran University of Medical Sciences Approved 2020-05-05 Ethics Committee of Iran University of Sciences Tehran. Valiasr St., Valinejad Alley. Shahid Hasheminejad Hospital tehran Tehran Iran (Islamic Republic of)