UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Urinary nerve growth factor and brain-derived neurotrophic factor levels in children with lower urinary tract symptom
Title of the study (Brief title)	Urinary NGF and BDNF in children with lower urinary tract symptom
Region	Japan

Condition
Condition	neurogenic bladder, lower urinary tract symptom, nocturnal enuresis
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify the urinary biomarkers in children with lower urinary tract dysfunction and nocturnal enuresis.
Basic objectives2	Others
Basic objectives -Others	To assess whether urinary NGF and/or BDNF is possible biomarkers for children with lower urinary tract dysfunction and nocturnal enuresis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To identify the urinary biomarker which correlates with dysfunctional voiding sympton scores.
Key secondary outcomes	Urinary NGF and BDNF before the treatment, 12 weeks after the treatment, and after the treatment

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	5 years-old <=
Age-upper limit	15 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with nocturnal enuresis and/or lower urinary tract symptom before treatments
Key exclusion criteria	Patients with underlying pathologic conditions such as renal, endocrine, metabolic, neurological disorders, urinary tract infection and malignant tumor
Target sample size	100

Research contact person
Name of lead principal investigator	Katsuya Aoki
Organization	Nara Medical University
Division name	Department of Urology
Address	840 Shijo-cho, Kashihara, Nara
TEL	0744-22-3051
Email	aokik@naramed-u.ac.jp

Public contact
Name of contact person	Katsuya Aoki
Organization	Nara Medical University
Division name	Department of Urology
Address	840 Shijo-cho, Kashihara, Nara
TEL	0744-22-3051
Homepage URL
Email	aokik@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

Funding Source
Organization	Nara Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 28 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 09 Month 18 Day
Anticipated trial start date	2013 Year 09 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	case-control study evaluation of levels of urinary NGF and BDNF

Management information
Registered date	2015 Year 12 Month 28 Day
Last modified on	2018 Year 07 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023476