Minirin Versus Oxybutynin for Nocturnal Enuresis in Children

Nocturnal Enuresis Clinical Trial

Official title:

Minirin Versus Oxybutynin for Nocturnal Enuresis in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02538302
• Other study ID #: 92.121.505
• Status: Completed
• Phase: Phase 3
• First received: August 27, 2015
• Last updated: August 29, 2015
• Start date: July 2013
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Hormozgan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 14 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enuresis
• Nocturnal Enuresis

Intervention

Drug:
• Minirin
Minirin 5 to 10 mg daily for 6 months
• Oxybutynin
Oxybutynin 5 to 10 mg daily for 6 months

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shahid Mohammadi hospital	Bandar Abbas	Hormozgan

Sponsors (1)

Lead Sponsor	Collaborator
Hormozgan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	?Frequency of nocturnal enuresis	Number of participants with nocturnal enuresis	6 months	No
Secondary	Frequency of urinary incontinency	Number of participants with urinary incontinency	6 months	No
Secondary	Frequency of urgency	Number of participants with urgency	6 months	No
Secondary	Frequency of Xerostomia	Number of participants with Xerostomia	6 months	Yes
Secondary	Frequency of Xerophthalmia	Number of participants with Xerophthalmia	6 months	Yes
Secondary	Frequency of Blurred vision	Number of participants with Blurred vision	6 months	Yes
Secondary	Frequency of Dysphagia	Number of participants with Dysphagia	6 months	Yes
Secondary	Frequency of constipation	Number of participants with constipation	6 months	Yes
Secondary	Frequency of Diarrhea	Number of participants with Diarrhea	6 months	Yes
Secondary	Frequency of Headache	Number of participants with Headache	6 months	Yes
Secondary	Frequency of Seizure	Number of participants with Seizure	6 months	Yes
Secondary	Frequency of Epistaxis	Number of participants with Epistaxis	6 months	Yes
Secondary	Frequency of Abdominal pain	Number of participants with Abdominal pain	6 months	Yes
Secondary	Frequency of Vomiting	Number of participants with Vomiting	6 months	Yes
Secondary	Frequency of Ear ache	Number of participants with Ear ache	6 months	Yes
Secondary	Frequency of Rhinitis	Number of participants with Rhinitis	6 months	Yes
Secondary	Frequency of Chest pain	Number of participants with Chest pain	6 months	Yes
Secondary	Frequency of Increase in appetite	Number of participants with Increase in appetite	6 months	Yes