Minirin Versus Oxybutynin for Nocturnal Enuresis in Children

Study Overview
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Brief Summary
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Nocturnal enuresis is among the most common disorders in children. The aim of current study was to compare the efficacy and safety of Minirin and oxybutynin for treatment of nocturnal enuresis in children in Bandar Abbas in 2014.

Detailed Description
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Nocturnal enuresis is among the most common disorders in children. Several pharmacological and non-pharmacological treatments are available for nocturnal enuresis. Studies for reaching the best pharmacological treatment for this disorder are continuing. The aim of current study was to compare the efficacy and safety of Minirin and oxybutynin for treatment of nocturnal enuresis in children in Bandar Abbas in 2014.

Official Title
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Minirin Versus Oxybutynin for Nocturnal Enuresis in Children

Conditions
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Nocturnal Enuresis

Intervention / Treatment
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* Drug: Minirin
* Drug: Oxybutynin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >5 years old Nocturnal enuresis Candidate for pharmacological treatment Exclusion Criteria: Children who their parents did noted filled the informed consent form Impossibility of follow up during the study period History of seizure History of rheumatologic disorders such as sjogren's disease

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minirin<br>120 microgram per day for 2 months, then 60 microgram per day for 2 months, then 60 microgram every two days for two months | Drug: Minirin<br>* Minirin 5 to 10 mg daily for 6 months<br>* Other names: Desmopressin acetate;|
| Active Comparator: Oxybutynin<br>5 mg Oxybutynin twice a daily for 6 months | Drug: Oxybutynin<br>* Oxybutynin 5 to 10 mg daily for 6 months<br>* Other names: Ditropan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ّFrequency of nocturnal enuresis | Number of participants with nocturnal enuresis | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of urinary incontinency | Number of participants with urinary incontinency | 6 months | 
| Frequency of urgency | Number of participants with urgency | 6 months | 
| Frequency of Xerostomia | Number of participants with Xerostomia | 6 months | 
| Frequency of Xerophthalmia | Number of participants with Xerophthalmia | 6 months | 
| Frequency of Blurred vision | Number of participants with Blurred vision | 6 months | 
| Frequency of Dysphagia | Number of participants with Dysphagia | 6 months | 
| Frequency of constipation | Number of participants with constipation | 6 months | 
| Frequency of Diarrhea | Number of participants with Diarrhea | 6 months | 
| Frequency of Headache | Number of participants with Headache | 6 months | 
| Frequency of Seizure | Number of participants with Seizure | 6 months | 
| Frequency of Epistaxis | Number of participants with Epistaxis | 6 months | 
| Frequency of Abdominal pain | Number of participants with Abdominal pain | 6 months | 
| Frequency of Vomiting | Number of participants with Vomiting | 6 months | 
| Frequency of Ear ache | Number of participants with Ear ache | 6 months | 
| Frequency of Rhinitis | Number of participants with Rhinitis | 6 months | 
| Frequency of Chest pain | Number of participants with Chest pain | 6 months | 
| Frequency of Increase in appetite | Number of participants with Increase in appetite | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minirin, Oxybutynin, Nocturnal enuresis