Minirin Versus Oxybutynin for Nocturnal Enuresis in Children

Sponsor

Hormozgan University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT02538302

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nocturnal Enuresis	Drug: Minirin Drug: Oxybutynin	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Minirin Versus Oxybutynin for Nocturnal Enuresis in Children

Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Minirin Minirin 5 to 10 mg daily for 6 months Other Names: Desmopressin acetate
Active Comparator: Oxybutynin 5 mg Oxybutynin twice a daily for 6 months	Drug: Oxybutynin Oxybutynin 5 to 10 mg daily for 6 months Other Names: Ditropan

Arm

Intervention/Treatment

Experimental: 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

Drug: Minirin

Minirin 5 to 10 mg daily for 6 months

Other Names:

Desmopressin acetate

Active Comparator: Oxybutynin

5 mg Oxybutynin twice a daily for 6 months

Drug: Oxybutynin

Oxybutynin 5 to 10 mg daily for 6 months

Other Names:

Ditropan

Outcome Measures

Primary Outcome Measures

ّFrequency of nocturnal enuresis [6 months]
Number of participants with nocturnal enuresis

Secondary Outcome Measures

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 Seizure [6 months]
Number of participants with Seizure
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