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IRCT20210613051564N1 IRCT 2021-07-19 Desmopressin plus tolterodine versus desmopressin plus indomethacin for pediatric enuresis Comparison of combination therapy with desmopressin plus tolterodine and desmopressin plus indomethacin for the treatment of pediatric enuresis 2018-03-21 anticipated 40 Complete https://irct.ir/trial/56846 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was done by simple randomization using the randomization table generated by the Random Allocation software with individuals as the unit of randomization. This table contained numbers from 1 to 40 and in front of each number the name of either of the groups were randomly mentioned. Based on this table, the study groups were written in sealed envelopes numbered from 1 to 40 and each envelope was allocated to a single patient in order of their entrance to the study. 2-3 Pediatric enuresis. Intervention 1: Intervention group: Desmopressin plus tolterodine: A 60 mcg desmopressin tablet from Ferring Pharmaceuticals Ltd., United Kindgdom, and a 2 mg tolterodine tablet from Alhavi Pharmaceutical Co., Iran, every night before bedtime. Intervention 2: Intervention group: Desmopressin plus indomethacin: A 60 mcg desmopressin tablet from Ferring Pharmaceuticals Ltd., United Kindgdom, and two 25 mg indomethacin capsules from Loghamn Pharmaceutical & Hygienic Co., Iran, every night before bedtime. Yes - There is a plan to make this available What will be shared: All collected data will be available after deidentification. When: Data will be available in 2022. To whom: People working in academic institutions Conditions: Eligible individuals will be able to use the data for pooled analysis Where to obtain: Via an email address: maryamesteghamati@gmail.com to Dr. Maryam Esteghamati How to obtain: Within a month of presenting a valid identification card Comments:
public Seyedeh Elaheh Mousavipour
Bandar Abbas Children's Hospital, Imam Khomeini Blvd., Bandar Abbas
Bandar Abbas Iran (Islamic Republic of) 7366579158 +98 76 3366 6242 mansor110110@yahoo.com Bandar Abbas Children's Hospital scientific Seyedeh Elaheh Mousavipour
Bandar Abbas Children's Hospital, Imam Khomeini Blvd., Bandar Abbas
Bandar Abbas Iran (Islamic Republic of) 7366579158 0098763366242 masor110110@yahoo.com Bandar Abbas Children's Hospital Iran (Islamic Republic of) Age >5 years and <18 years Diagnosis of mono- or disymptomatic enuresis 6 years 17 years Both Having previously received any treatment for enuresis Secondary causes of enuresis, including anatomic disorders of the urinary system, trauma, constipation, diabetes mellitus, diabetes insipidus, urinary tract infection, and the like. N39.44 Nocturnal enuresis Treatment - Drugs Treatment - Drugs Intervention group: Desmopressin plus tolterodine: A 60 mcg desmopressin tablet from Ferring Pharmaceuticals Ltd., United Kindgdom, and a 2 mg tolterodine tablet from Alhavi Pharmaceutical Co., Iran, every night before bedtime Intervention group: Desmopressin plus indomethacin: A 60 mcg desmopressin tablet from Ferring Pharmaceuticals Ltd., United Kindgdom, and two 25 mg indomethacin capsules from Loghamn Pharmaceutical & Hygienic Co., Iran, every night before bedtime Response to treatment in the form of the number of dry nights per month. Timepoint: 1, 3, and 5 months after the initiation of treatment. Method of measurement: By asking the children's parents. Technology and Research Vice-chancellery, Hormozgan University of Medical Sciences Technology and Research Vice-chancellery, Hormozgan University of Medical Sciences Approved 2018-05-13 Ethics Committee of Hormozgan University of Medical Sciences Technology and Research Vice-chancellery, East side of Payambar Azam Hospital, Bandar Abbas Bandar Abbas Hormozgan Iran (Islamic Republic of)