Urinary Neurotrophin Levels in Healthy Children

NCT ID: NCT02389270

Last Updated: 2016-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-12-31

Brief Summary

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The aim of this study is to analyse urinary neurotrophin levels in healthy children. Urine samples will be collected at 3 different times of day (morning, noon, and evening) at urge sensation from all age groups of children who gained bladder control, i.e. from 3-18 years of age. Urinary levels of nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF) normalised to urinary creatinine will be analysed. Age and daytime related variations will be reported for both boys and girls. These results will contribute to understanding the role of neurotrophins in the physiology of lower urinary tract and pathophysiology of idiopathic and secondary hyperactive bladder in children.

Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy children

Healthy children without lower urinary tract diseases, history of urinary tract infection, chronic diseases, anomalies of urinary or genital tract, and remarkable clinical examination.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 3-18 years of age
* a unremarkable clinical examination
* a normal voiding pattern
* a minimum of 3 micturitions per day
* informed oral and written consent from the child and both parents/legal guardian

Exclusion Criteria

* history of urinary tract infection
* diseases of central or peripheral nerve system
* anomalies of lumbosacral region
* chronic diseases
* operative procedures or anomalies of urinary or genital tract
* lower urinary tract symptoms
* constipation
* hypercalcuria
* urolithiasis, depression, eating disorders or cardio-metabolic diseases
* prior use of anticholinergic treatment
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital Zagreb

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Slaven Abdovic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Zagreb

Central Contacts

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Slaven Abdovic, MD, PhD

Role: CONTACT

+38514600132

Other Identifiers

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pOAB-CHZ-00

Identifier Type: -

Identifier Source: org_study_id

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