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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02699528
Other study ID # MMC-15-0329
Secondary ID
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


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
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