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Completed

NCT Number: NCT02538302

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.

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Key information

Conditions

Nocturnal Enuresis Behavior Behavioral Symptoms Elimination Disorders Enuresis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Mental Disorders Urination Disorders Urogenital Diseases Urologic Diseases

Age range

5 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shahid Mohammadi hospital

Bandar Abbas, Hormozgan, 79176, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minirin

Drug

Minirin 5 to 10 mg daily for 6 months

Other names: Desmopressin acetate

Oxybutynin

Drug

Oxybutynin 5 to 10 mg daily for 6 months

Other names: Ditropan

Primary outcomes

  1. ّFrequency of nocturnal enuresis

    Time frame: 6 months

    Number of participants with nocturnal enuresis

Secondary outcomes

  1. Frequency of urinary incontinency

    Time frame: 6 months

    Number of participants with urinary incontinency

  2. Frequency of urgency

    Time frame: 6 months

    Number of participants with urgency

  3. Frequency of Xerostomia

    Time frame: 6 months

    Number of participants with Xerostomia

  4. Frequency of Xerophthalmia

    Time frame: 6 months

    Number of participants with Xerophthalmia

  5. Frequency of Blurred vision

    Time frame: 6 months

    Number of participants with Blurred vision

  6. Frequency of Dysphagia

    Time frame: 6 months

    Number of participants with Dysphagia

  7. Frequency of constipation

    Time frame: 6 months

    Number of participants with constipation

  8. Frequency of Diarrhea

    Time frame: 6 months

    Number of participants with Diarrhea

  9. Frequency of Headache

    Time frame: 6 months

    Number of participants with Headache

  10. Frequency of Seizure

    Time frame: 6 months

    Number of participants with Seizure

  11. Frequency of Epistaxis

    Time frame: 6 months

    Number of participants with Epistaxis

  12. Frequency of Abdominal pain

    Time frame: 6 months

    Number of participants with Abdominal pain

  13. Frequency of Vomiting

    Time frame: 6 months

    Number of participants with Vomiting

  14. Frequency of Ear ache

    Time frame: 6 months

    Number of participants with Ear ache

  15. Frequency of Rhinitis

    Time frame: 6 months

    Number of participants with Rhinitis

  16. Frequency of Chest pain

    Time frame: 6 months

    Number of participants with Chest pain

  17. Frequency of Increase in appetite

    Time frame: 6 months

    Number of participants with Increase in appetite

Sponsors and collaborators

Lead sponsor

Hormozgan University of Medical Sciences

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 2, 2015
Registry last updated
Sep 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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