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IRCT20141224020419N3 IRCT 2019-07-02 Mazandaran University of Medical Sciences Efficacy of Tolterodine versus Oxybutynin in treatment of enuresis Clinical trial of comparison of the efficacy of Tolterodine versus Oxybutynin in treatment of enuretic children resistant to Desmopressin 2018-11-22 anticipated 61 Complete https://irct.ir/trial/35115 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be divided into two groups with statistical software receiving Tolterodine plus desmopressin or oxybutynin plus desmopressin for three months by simple randomization method, Blinding description: The patient, investigator, and data analyzer will not be aware about the type of drug. 2-3 Noctural enuresis. Intervention 1: Intervention first group: The group receiving tolterodine (Made by Iran Daroo Co, 05-4 mg every night) 0.5 mg every night after dinner than could be titrated to 4 mg + desmopressin (Made by Iran Daroo Co, with dose of one 10 microgram puff on one side of the nose every night before bed which increase to two puffs of 20 microgram on every nose based on clinical response) for 12 weeks. Intervention 2: The second intervention group: The group receiving oxybutynin (Made by Iran Daroo Co, 0.2 mg/kg every night before bed)+ desmopressin (Made by Iran Daroo Co, with dose of one 10 microgram puff on one side of the nose every night before bed which increase to two puffs of 20 microgram on every nose based on clinical response) for 12 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 Due to the confidentiality of the information and the dissatisfaction of the participants
public Hamid Mohammadjaafari
Booali hospital, Pasdaran boulevard, Sari
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 2334 hamidmjaafari@yahoo.com Mazandaran University of Medical Sciences scientific Neda Ezoddin
Booali hospital, Sari, Iran
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 2334 nezoddin@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Primary enuresis No evidence of secondary enuresis in clinical examination, urine analysis and sonography No response to nasal desmopressine 5 years 18 years Both Secondary enuresis Underlying genitourinary system anomalies Interruption of follow up of the patient R32 Unspecified urinary incontinence Treatment - Drugs Treatment - Drugs Intervention first group: The group receiving tolterodine (Made by Iran Daroo Co, 05-4 mg every night) 0.5 mg every night after dinner than could be titrated to 4 mg + desmopressin (Made by Iran Daroo Co, with dose of one 10 microgram puff on one side of the nose every night before bed which increase to two puffs of 20 microgram on every nose based on clinical response) for 12 weeks The second intervention group: The group receiving oxybutynin (Made by Iran Daroo Co, 0.2 mg/kg every night before bed)+ desmopressin (Made by Iran Daroo Co, with dose of one 10 microgram puff on one side of the nose every night before bed which increase to two puffs of 20 microgram on every nose based on clinical response) for 12 weeks Noctural enuresis in night. Timepoint: Beginning of the study, 6 and 12 weeks after beginning of the study. Method of measurement: The frequency of wetting every night. Noctural enuresis in week. Timepoint: Beginning of the study, 6 and 12 weeks after beginning of the study. Method of measurement: The frequency of wetting in week. Mazandaran University of Medical Sciences Approved 2019-05-18 Ethics committee of Māzandarān University of Medical Sciences Moalem Sari Mazandaran Iran (Islamic Republic of)