Urinary Neurotrophin Levels in Healthy Children

• Conditions: Overactive Bladder

• Registration Number: NCT02389270
• Lead Sponsor: Children's Hospital Zagreb

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2015-03-10
• Study First Submitted QC: 2015-03-10
• Study First Posted: 2015-03-17
• Status Verified: 2016-03
• Study Start: 2016-03
• Last Update Submitted: 2016-03-05
• Last Update Posted: 2016-03-08
• Primary Completion: 2016-08
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concentration of urinary nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF) normalised to urinary creatinin	Collection of urine samples and analysis will take approximately 6 months.	We will collect urine samples from healthy children without lower urinary tract symptoms and analyse urine concentrations of neurotrophins (NGF and BDNF) normalised to urinary creatinin in order to report its normal age- and daytime-related variations.