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Minirin Versus Oxybutynin for Nocturnal Enuresis in Children

Primary Purpose

Nocturnal Enuresis

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Minirin
Oxybutynin
Sponsored by
Hormozgan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturnal Enuresis focused on measuring Minirin, Oxybutynin, Nocturnal enuresis

Eligibility Criteria

5 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shahid Mohammadi hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Minirin

Oxybutynin

Arm Description

120 microgram per day for 2 months, then 60 microgram per day for 2 months, then 60 microgram every two days for two months

5 mg Oxybutynin twice a daily for 6 months

Outcomes

Primary Outcome Measures

ّFrequency of nocturnal enuresis
Number of participants with nocturnal enuresis

Secondary Outcome Measures

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

Full Information

First Posted
August 27, 2015
Last Updated
August 29, 2015
Sponsor
Hormozgan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02538302
Brief Title
Minirin Versus Oxybutynin for Nocturnal Enuresis in Children
Official Title
Minirin Versus Oxybutynin for Nocturnal Enuresis in Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hormozgan University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturnal Enuresis
Keywords
Minirin, Oxybutynin, Nocturnal enuresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minirin
Arm Type
Experimental
Arm Description
120 microgram per day for 2 months, then 60 microgram per day for 2 months, then 60 microgram every two days for two months
Arm Title
Oxybutynin
Arm Type
Active Comparator
Arm Description
5 mg Oxybutynin twice a daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Minirin
Other Intervention Name(s)
Desmopressin acetate
Intervention Description
Minirin 5 to 10 mg daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Oxybutynin
Other Intervention Name(s)
Ditropan
Intervention Description
Oxybutynin 5 to 10 mg daily for 6 months
Primary Outcome Measure Information:
Title
ّFrequency of nocturnal enuresis
Description
Number of participants with nocturnal enuresis
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Frequency of urinary incontinency
Description
Number of participants with urinary incontinency
Time Frame
6 months
Title
Frequency of urgency
Description
Number of participants with urgency
Time Frame
6 months
Title
Frequency of Xerostomia
Description
Number of participants with Xerostomia
Time Frame
6 months
Title
Frequency of Xerophthalmia
Description
Number of participants with Xerophthalmia
Time Frame
6 months
Title
Frequency of Blurred vision
Description
Number of participants with Blurred vision
Time Frame
6 months
Title
Frequency of Dysphagia
Description
Number of participants with Dysphagia
Time Frame
6 months
Title
Frequency of constipation
Description
Number of participants with constipation
Time Frame
6 months
Title
Frequency of Diarrhea
Description
Number of participants with Diarrhea
Time Frame
6 months
Title
Frequency of Headache
Description
Number of participants with Headache
Time Frame
6 months
Title
Frequency of Seizure
Description
Number of participants with Seizure
Time Frame
6 months
Title
Frequency of Epistaxis
Description
Number of participants with Epistaxis
Time Frame
6 months
Title
Frequency of Abdominal pain
Description
Number of participants with Abdominal pain
Time Frame
6 months
Title
Frequency of Vomiting
Description
Number of participants with Vomiting
Time Frame
6 months
Title
Frequency of Ear ache
Description
Number of participants with Ear ache
Time Frame
6 months
Title
Frequency of Rhinitis
Description
Number of participants with Rhinitis
Time Frame
6 months
Title
Frequency of Chest pain
Description
Number of participants with Chest pain
Time Frame
6 months
Title
Frequency of Increase in appetite
Description
Number of participants with Increase in appetite
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamidreza Mahboobi, M.D
Organizational Affiliation
Hormozgan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shahid Mohammadi hospital
City
Bandar Abbas
State/Province
Hormozgan
ZIP/Postal Code
79176
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
27123229
Citation
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.
Results Reference
derived

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Minirin Versus Oxybutynin for Nocturnal Enuresis in Children

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