Minirin Versus Oxybutynin for Nocturnal Enuresis in Children

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: July 2015

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.

Interventions

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

Arms, Groups and Cohorts

  • 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
  • Active Comparator: Oxybutynin
    • 5 mg Oxybutynin twice a daily for 6 months

Clinical Trial Outcome Measures

Primary Measures

  • Ù‘Frequency of nocturnal enuresis
    • Time Frame: 6 months
    • Number of participants with nocturnal enuresis

Secondary Measures

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

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: 5 Years

    Maximum Age: 14 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Hormozgan University of Medical Sciences
    • Provider of Information About this Clinical Study
      • Principal Investigator: Hamidreza Mahboobi, Principal Investigator – Hormozgan University of Medical Sciences
    • Overall Official(s)
      • Hamidreza Mahboobi, M.D, Principal Investigator, Hormozgan University of Medical Sciences

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