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IRCT20220520054929N1 IRCT 2022-09-05 Zahedan University of Medical Sciences Evaluation of the effect of sulifenacin and tolterodine in the treatment of primary enuresis in children Comparison of efficacy and tolerability of pediatric primary enuresis treatment with Solifenacin and Tolterodine in children 2022-09-16 anticipated 66 Complete https://irct.ir/trial/64106 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: The sampling method in this study will be available based on the entry and exit criteria, and the random allocation of patients to two groups will be done with the permuted block stratified randomization method. In this way, first, eligible referring patients are classified according to age and gender in the order of entry. Then they are assigned to the desired group based on blocks of 4 (consisting of two groups A and B and two repetitions for each) randomly selected from among all the possible states of permutations. These blocks were created using statistical software R version 4.0.2, Blinding description: Patients will enter the study after completing the informed consent and explaining the content of the study. The blinding process will be as follows: Patients will be treated with prescription packages pre-determined by the study supervisor (supervisor). Drug packages are quite similar in shape and the project manager is not aware of the contents of the packages. In addition, information collection, patient assessment and completion of forms is done by the project manager and his assistant who are not aware 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) will be determined to analyze the data; Therefore, the study is three-blind and the contents of the two drug groups are not clear from the stage of the patient entering the study to perform the study, data collection and data analysis. 3 pediatric primary enuresis. Intervention 1: Intervention group 1: Solifenacin treated group (this group will be treated with Solifenacin 5 mg every night, manufactured by Caspin Daru Company, Rasht, Iran for 3 months. Then the patients were visited at the end of the first and third month and the amount Nocturnal enuresis, incidence of side effects (in the solifenacin group included dry mouth, constipation, abdominal pain and nausea) will be evaluated. Intervention 2: Intervention group 2: Tolterodine treated group. Yes - There is a plan to make this available What will be shared: All the studied data (without identity information) will be obtained. When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions related to medical sciences Conditions: The data will be placed in the form of all valid people (ensuring that the people are researchers). Where to obtain: Fatemeh Ghaderi (responsible for updating the study), contact: fatemeh.ghaderi@zaums.ac.ir How to obtain: Please send your request to the attached email. The data will be available to the applicants 6 months after the publication of the results in the publishers. (The data will be served to people within a week after the request). Comments:
public Fateme Ghaderi
Salamat Blvd., Persian Gulf Highway, Zahedan City
Zahedan Iran (Islamic Republic of) 9816743111 +98 54 3329 5570 fatemeh.ghaderi@zaums.ac.ir Zahedan University of Medical Sciences scientific Saeed Movahed
Salamat Blvd., Persian Gulf Highway, Zahedan City
Zahedan Iran (Islamic Republic of) 9816743111 +98 54 3329 5570 drsaeedmovahed@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Children with primary enuresis referred to the clinic of Ali Bin Abi Talib Hospital in Zahedan Conscious consent to study Patient availability during quarterly follow-up Age 5 to 14 years 5 years 14 years Both Structural disorders of the urinary tract Neurological bladder Psychiatric diseases Previous allergy to drugs History of taking medication (drug therapy) for enuresis Urinary incontinence N39.44 Nocturnal enuresis Treatment - Drugs Treatment - Drugs Intervention group 1: Solifenacin treated group (this group will be treated with Solifenacin 5 mg every night, manufactured by Caspin Daru Company, Rasht, Iran for 3 months. Then the patients were visited at the end of the first and third month and the amount Nocturnal enuresis, incidence of side effects (in the solifenacin group included dry mouth, constipation, abdominal pain and nausea) will be evaluated. Intervention group 2: Tolterodine treated group Enuresis status (number of times). Timepoint: Before the intervention, one month and three months after the intervention. Method of measurement: Number of enuresis nights during 1 month. Full recovery. Timepoint: 3 months after the intervention. Method of measurement: Based on the patient's history. Complications during the intervention. Timepoint: During the 3 months of intervention. Method of measurement: Based on the patient's history. Satisfaction with treatment. Timepoint: 3 months after the intervention. Method of measurement: Based on the 5-point criterion after taking the drug. Zahedan University of Medical Sciences Approved 2022-05-15 Research Ethics Committees of Zahedan University Of Medical Sciences ZAUMS Main campus, Zahedan, Sistan and Baluchestan, Iran Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)