The effect of Boron supplement on severity and duration of colic pain and the time of expulsion of urinary stone after Extracorporeal Shock Wave Lithotripsy compared to Tamsulosin

Determination of the effect of Boron supplement on stone expulsion rate after extra corporeal shock wave lithotripsy compared with tamsulosin

Clinical trial with control group,parallel groups, single blinded, randomised

Patients over 18 years old after ESWL and filling out an informed consent form will include in the study. we assessed height and weight, medications and previous illness history of participants. Then Patients randomly will treat with Boron supplement (10 mg/BD) or Tamsulosin (0.4 mg/day) for 14 days . Recommendations for increase fluid intake and use analgesics (NSAIDs) if needed were given to patients. Patients will comeback with ultra- sonography or KUB two weeks after the intervention. Questionnaires regarding stone expulsion rate, stone expulsion time, patient's pain severity according to VAS scale, drug side effects, and the number of used analgesic were completed in addition to the assessment of serum creatinine and urine analysis.

Patients over 18 years of age referred to the Extracorporeal Shock Wave Lithotripsy section of the Labbafinejad Clinic who did not have urinary tract infection or chronic kidney disease and had no history of urinary tract surgery (PCNL or open stone). They also do not have contraindications to ESWL, including pregnancy and unmodified coagulopathy, and do not have estrogen-dependent cancers (breast, endometrial, and ovarian). The lactated women were not included in the study.

َAdults more than 18 years of old after ESWL treated with Boron supplement 10 mg/BD (sodium tetraborate decahydrate; Sigma, St. Louis, USA) in intervention group or with CapTamsulosin 0.4 mg/every night (Tasnim pharmaceutical Co.) in control group

The remained stone size, stone expulsion time and the patient's pain severity (according to VAS scale)

Block randomization with the block size of four was used, to randomly allocate the patients to Boron and Tamsulosin groups and balance patient allocation between groups. Random Allocation software was used to generate random sequences. Given the random sequences generated, patients were divided into two groups.

According to the apparent difference between tamsulosin (14 capsule) and boron (28 capsule) appearance and the numbers of drug needed in two groups, both participants and care provider not blinded during the study. But in the data analysis phase, data analyzer colleague was blinded regarding the type of drug prescribed in two patients group.

The information about the type of treatment and the patients questionnaires will be available.

The data could be available one year after the publication of the results.

Data will be available for academic faculty members and researchers.

The control of the data and supplementary analyses of the data could be performed under copyright law.

Urology and Nephrology Research Center: Dr. Maryam Taheri: taheri233@yahoo.com/ Ms. Shabnam Golshan: +98-21-22567222

The applicant must submit a written request to the Urology and Nephrology Research Center. After the approval of the center and the PI of the proposal, the data will be available to the applicant.