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IRCT20190119042410N1 IRCT 2020-07-05 Boushehr University of Medical Sciences The efficacy of combination therapy of toltrodine and tamsulosin on urinary symptoms The comparison of the Efficacy and Safety of Combination of Tamsulosin with Tolterodin and Tamsulosin alone In the Treatment of Double-J Stent Related Urinary Tract Symptoms 2019-09-23 anticipated 50 Complete https://irct.ir/trial/36928 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with inclusion criteria who do not have exclusion criteria will enter the study. Allocation of patients to each of the two intervention groups is done by simple random assignment method. Unit of randomization will be each individual person. Random number tables available at http://www.rand.org/publications/classics/randomdigits will be used for randomization. This table is ordered in blocks of five. The first number in the fist block of first page will be chosen and moving horizontally the first number of each block will be selected. Odds and even number will be allocated to each group.The secretary of clinic extracted all numbers before the start of recruitment of cases. She write all numbers in a list and patients will recieve each intervention according to the list. No more action will be done for allocation concealment, Blinding description: The capsules are provided to patients by the physician encoded packages and the patient's drug code will be provided to the analyst, but completion of the questionnaire will be done by a third person (student) who is not aware of the codes. 3 Urinary symptoms caused by stent. Intervention 1: Intervention group 1 Tamsulosin 0.4 mg daily for 2 weeks. Intervention 2: Intervention group 2 Tamsulosin 0.4 mg daily for 2 weeks and Toltrodine 2 mg daily for 2 weeks. 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 There is no further information
public Farshad zohrabi
Bushehr University of Medical Sciences and Health Services, in front of the Friday prayer place, Moallem Street
Bushehr Iran (Islamic Republic of) 7514633341 +98 77 3332 0657 zohrabi.fsh@gmail.com Boushehr University of Medical Sciences scientific Motamed Niloofar
Bushehr University of Medical Sciences and Health Services, in front of the Friday prayer place, Moallem Street
bushehr Iran (Islamic Republic of) 7514633341 +98 77 3332 0657 motamedn@bpums.ac.ir Boushehr University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years of age Completion of written consent form One-way ureteral stenting after ureteroscopy and TUL for ureteral stones Negative urine culture prior to TUL and stents male 18 years no limit Male Physician diagnosed sensitivity to tamsulosin, toltrodine or folic acid Establishment of ureteral stent during the last 6 months Treatment - Drugs Treatment - Drugs Intervention group 1 Tamsulosin 0.4 mg daily for 2 weeks Intervention group 2 Tamsulosin 0.4 mg daily for 2 weeks and Toltrodine 2 mg daily for 2 weeks Score from the USSQ Questionnaire. Timepoint: Start studying and two weeks later. Method of measurement: USSQ Questionnaire. Boushehr University of Medical Sciences Approved 2019-05-20 Ethics committee of Bushehr University of Medical Sciences Clinical Research Development Center, Ground floor, Training Hall, Taleghani Ave., Bushehr, Bushehr, Iran Bushehr Boushehr Iran (Islamic Republic of)