The Effect of Methylphenidate on Primary Enuresis in Children With Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Does Methylphenidate, Prescribed for Attention Deficit Disorder, Influence Primary Enuresis in These Children?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02699528
• Other study ID #: MMC-15-0329
• Status: Recruiting
• Phase: N/A
• First received: February 2, 2016
• Last updated: September 15, 2016
• Start date: May 2016
• Est. completion date: May 2017

Study information

• Verified date: September 2016
• Source: Meir Medical Center
• Contact: Florence Katz, BA
• Phone: 972-9-7471803
• Email: florence.katz[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

To assess wether methylphenidate reduces the prevalence of primary nocturnal enuresis in children with attention deficit disorder

Description:

Children aged 5 - 10 years newly diagnosed with attention deficit hyperactivity disorder who report primary nocturnal enuresis, Investigators will obtain baseline data (from parents/caregivers) on their sleep habits and enuresis characteristics by questionnaire. After 6 weeks of methylphenidate therapy, prescribed for the attention deficit, a new questionnaire will be filled.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 10 Years

Eligibility

Inclusion Criteria:

• New diagnosis of attention deficit hyperactivity disorder

• History of primary nocturnal enuresis

• Normal neurological examination

Exclusion Criteria:

• Anatomical abnormality of the genitourinary system

• Concommitant treatment, pharmacological/behavioral for enuresis

• Concommitant diurnal enuresis

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Disease
• Enuresis
• Hyperkinesis
• Nocturnal Enuresis
• Urinary Incontinence

Intervention

Drug:
• methylphenidate
The drug will be prescribed as indicated for attention deficit disorder

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A reduction in nocturnal enuresis frequency		6 weeks	No