NCT02538302

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
Last Updated

September 2, 2015

Status Verified

August 1, 2015

Enrollment Period

2 years

First QC Date

August 27, 2015

Last Update Submit

August 29, 2015

Conditions

Nocturnal Enuresis

Keywords

MinirinOxybutyninNocturnal enuresis

Outcome Measures

Primary Outcomes (1)

  • ّFrequency of nocturnal enuresis

    Number of participants with nocturnal enuresis

    6 months

Secondary Outcomes (17)

  • Frequency of urinary incontinency

    6 months

  • Frequency of urgency

    6 months

  • Frequency of Xerostomia

    6 months

  • Frequency of Xerophthalmia

    6 months

  • Frequency of Blurred vision

    6 months

  • +12 more secondary outcomes

Study Arms (2)

Minirin

EXPERIMENTAL

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

Oxybutynin

ACTIVE COMPARATOR

5 mg Oxybutynin twice a daily for 6 months

Drug: Oxybutynin

Interventions

MinirinDRUG

Minirin 5 to 10 mg daily for 6 months

Also known as: Desmopressin acetate
Minirin
OxybutyninDRUG

Oxybutynin 5 to 10 mg daily for 6 months

Also known as: Ditropan
Oxybutynin

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \>5 years old
  • Nocturnal enuresis
  • Candidate for pharmacological treatment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Mohammadi hospital

Bandar Abbas, Hormozgan, 79176, Iran

Location

Related Publications (1)

  • 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.

    PMID: 27123229DERIVED

MeSH Terms

Conditions

Nocturnal Enuresis

Interventions

Deamino Arginine Vasopressinoxybutynin

Condition Hierarchy (Ancestors)

EnuresisUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Arginine VasopressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Hamidreza Mahboobi, M.D

    Hormozgan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 27, 2015

First Posted

September 2, 2015

Study Start

July 1, 2013

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

September 2, 2015

Record last verified: 2015-08

Locations

IR(1)