Minirin Versus Oxybutynin for Nocturnal Enuresis in Children

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.

Study Overview

• Status: Completed
• Conditions: Nocturnal Enuresis
• Intervention / Treatment: Drug: Minirin; Drug: Oxybutynin

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Hormozgan
    • Bandar Abbas, Hormozgan, Iran, Islamic Republic of, 79176
      • Shahid Mohammadi hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hormozgan University of Medical Sciences
• Investigators: Principal Investigator: Hamidreza Mahboobi, M.D, Hormozgan University of Medical Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: August 27, 2015
• First Submitted That Met QC Criteria: August 29, 2015
• First Posted (Estimate): September 2, 2015

Study Record Updates

• Last Update Posted (Estimate): September 2, 2015
• Last Update Submitted That Met QC Criteria: August 29, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Oxybutynin; Minirin; Nocturnal enuresis
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Nocturnal Enuresis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Natriuretic Agents; Hemostatics; Coagulants; Antidiuretic Agents; Oxybutynin; Deamino Arginine Vasopressin
• Other Study ID Numbers: 92.121.505