Minirin Versus Oxybutynin for Nocturnal Enuresis in Children

Phase 3

Completed

• Conditions: Nocturnal Enuresis
• Interventions: Drug: Minirin; Drug: Oxybutynin

• Registration Number: NCT02538302
• Lead Sponsor: Hormozgan University of Medical Sciences

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.

Study Timeline

• Study Start: 2013-07
• Primary Completion: 2015-07
• Status Verified: 2015-08
• Study Completion: 2015-08
• Study First Submitted: 2015-08-27
• Study First Submitted QC: 2015-08-29
• Last Update Submitted: 2015-08-29
• Study First Posted: 2015-09-02
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minirin	Minirin	120 microgram per day for 2 months, then 60 microgram per day for 2 months, then 60 microgram every two days for two months
Oxybutynin	Oxybutynin	5 mg Oxybutynin twice a daily for 6 months

Primary Outcome Measures

Name	Time	Method
ّFrequency of nocturnal enuresis	6 months	Number of participants with nocturnal enuresis

Secondary Outcome Measures

Name	Time	Method
Frequency of Seizure	6 months	Number of participants with Seizure
Frequency of urinary incontinency	6 months	Number of participants with urinary incontinency
Frequency of urgency	6 months	Number of participants with urgency
Frequency of Xerostomia	6 months	Number of participants with Xerostomia
Frequency of Xerophthalmia	6 months	Number of participants with Xerophthalmia
Frequency of Blurred vision	6 months	Number of participants with Blurred vision
Frequency of Dysphagia	6 months	Number of participants with Dysphagia
Frequency of constipation	6 months	Number of participants with constipation
Frequency of Diarrhea	6 months	Number of participants with Diarrhea
Frequency of Headache	6 months	Number of participants with Headache
Frequency of Epistaxis	6 months	Number of participants with Epistaxis
Frequency of Abdominal pain	6 months	Number of participants with Abdominal pain
Frequency of Vomiting	6 months	Number of participants with Vomiting
Frequency of Ear ache	6 months	Number of participants with Ear ache
Frequency of Rhinitis	6 months	Number of participants with Rhinitis
Frequency of Chest pain	6 months	Number of participants with Chest pain
Frequency of Increase in appetite	6 months	Number of participants with Increase in appetite

Trial Locations

Locations (1)

Shahid Mohammadi hospital; 🇮🇷 Bandar Abbas, Hormozgan, Iran, Islamic Republic of