Urinary Neurotrophin Levels in Healthy Children

Overactive Bladder Clinical Trial

Official title:

Age and Daytime Variations in Urinary Neurotrophin Levels in Healthy Children Without Lower Urinary Tract Symptoms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02389270
• Other study ID #: pOAB-CHZ-00
• Status: Not yet recruiting
• Phase: N/A
• First received: March 10, 2015
• Last updated: March 5, 2016
• Start date: March 2016
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: Children's Hospital Zagreb
• Contact: Slaven Abdovic, MD, PhD
• Phone: +38514600132
• Email: sabdovic[@]gmail.com
• Is FDA regulated: No
• Health authority: Croatia: Ministry of Health and Social Care
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Overactive Bladder
• Urinary Bladder, Overactive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Zagreb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of urinary nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF) normalised to urinary creatinin	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.	Collection of urine samples and analysis will take approximately 6 months.	No