Clinical trial NCT02538302: Minirin Versus Oxybutynin for Nocturnal Enuresis in Children
Official title: Minirin Versus Oxybutynin for Nocturnal Enuresis in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nocturnal Enuresis
Keywords: Minirin
Oxybutynin
Nocturnal enuresis
Lead sponsor: Hormozgan University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-09-02
Enrollment: 66
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: ّFrequency of nocturnal enuresis
timeFrame: 6 months
Secondary outcomes:
measure: Frequency of urinary incontinency
timeFrame: 6 months
measure: Frequency of urgency
timeFrame: 6 months
measure: Frequency of Xerostomia
timeFrame: 6 months
measure: Frequency of Xerophthalmia
timeFrame: 6 months
measure: Frequency of Blurred vision
timeFrame: 6 months
measure: Frequency of Dysphagia
timeFrame: 6 months
measure: Frequency of constipation
timeFrame: 6 months
measure: Frequency of Diarrhea
timeFrame: 6 months
measure: Frequency of Headache
timeFrame: 6 months
measure: Frequency of Seizure
timeFrame: 6 months
measure: Frequency of Epistaxis
timeFrame: 6 months
measure: Frequency of Abdominal pain
timeFrame: 6 months
measure: Frequency of Vomiting
timeFrame: 6 months
measure: Frequency of Ear ache
timeFrame: 6 months
measure: Frequency of Rhinitis
timeFrame: 6 months
measure: Frequency of Chest pain
timeFrame: 6 months
measure: Frequency of Increase in appetite
timeFrame: 6 months
Other outcomes:
Locations:
city: Bandar Abbas
country: Iran, Islamic Republic of
facility: Shahid Mohammadi hospital
state: Hormozgan
Study officials:
affiliation: Hormozgan University of Medical Sciences
name: Hamidreza Mahboobi, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ghasemi K, Esteghamati M, Mohammadzadeh M, Zare S. Desmopressin versus Oxybutynin for Nocturnal Enuresis in Children in Bandar Abbas: A Randomized Clinical Trial. Electron Physician. 2016 Mar 25;8(3):2187-93. doi: 10.19082/2187. eCollection 2016 Mar.