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

Determining the effect of tamsulosin, hydrochlorothiazide or concomitant use of both in increasing the risk of stone excretion after ESWL

Patients will be grouped according to the Balanced Block Randomization method into four groups, A and B, C and D. All four drugs are in boxes A, B, C and D, and only the doctor in charge of the project is aware of the drug's content in each group. Then, for each patient, numbering is done by the supervisor and what is remembered in the office. For example, patient number 1 is drug A and patient number 2 is drug B, or vice versa, which is described below.

Kidneys are patients who have kidney stones in the upper ureter that are less than 2 cm in diameter on ultrasound and initial CT scan and are hospitalized at Shahid Hasheminejad Hospital in Tehran.

The subjects included all patients with kidney stones in the upper ureter who were less than 2 cm in diameter on ultrasound and initial CT scan and were admitted to Shahid Hasheminejad Hospital in Tehran, and were selected as a non-probable sequence. The criteria for withdrawal from the study include patient dissatisfaction at any stage of the study, lack of cooperation and non-use of the desired drugs, history of nephrolithiasis surgery, moderate and severe hydronephrosis, and renal failure.

All patients are advised to limit their salt diet and increase their fluid intake. They are then randomly assigned to each of the groups studied. The first group with tamsulosin (0.4 mg ) and the second group with hydrochlorothiazide (25 mg twice daily), the third group under tamsulosin (0.4) mg / day) and hydrochlorothiazide (25 mg twice daily) and the fourth group as the control group will receive only painkillers with placebo.

The effect of the drug on stone excretion

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.

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