Comparison of efficacy and tolerability of pediatric primary enuresis treatment with Solifenacin and Tolterodine in children

Comparison of efficacy and tolerability of solifenacin and tolterodine in the treatment of primary enuresis in children. comparing the average number of enuresis in the month before the intervention, one month, and three months after the intervention in children. comparing the frequency of complete recovery after 3 months of treatment in children. comparing the frequency of drug side effects in children. comparing the average satisfaction at the end of three months of treatment in children.

A clinical trial with parallel, blind, randomized, phase 3 groups will be performed on 66 patients and permutation blocks will be used for randomization.

This research will be conducted in the urology clinic of Ali Bin Abi Talib Zahedan Hospital. This clinical trial study with the participation of 66 children with primary nocturnal enuresis (in two groups of 33 people) will be treated with solifenacin and tolterodine drugs, and the patient's recovery, satisfaction with the treatment, and its side effects will be evaluated.

The study population: children with primary enuresis who referred to the urology clinic of Ali Ibn Abi Talib Hospital in Zahedan, Iran in 2022. Inclusion criteria: Patient availability during follow-up and Age 5 to 14 years. exclusion criteria: Structural disorders of the urinary tract; Neurological bladder; Psychiatric diseases; Previous allergy to drugs and History of taking medication (drug therapy) for enuresis and Urinary incontinence.

1- children who will be treated with tolterodine 2 mg per night, made by Daru Pakhsh Company, Iran. 2- children who will be treated with solifenacin 5 mg per night, made by Caspian Daru Company, Iran.

Number of enuresis, satisfaction with treatment, expected complications, complete recovery

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.

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.

All the studied data (without identity information) will be obtained.

The access period starts 6 months after the results are published

Researchers working in academic and scientific institutions related to medical sciences

The data will be placed in the form of all valid people (ensuring that the people are researchers).

Fatemeh Ghaderi (responsible for updating the study), contact: fatemeh.ghaderi@zaums.ac.ir

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).