UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020390 |
|---|---|
| Receipt number | R000023476 |
| Scientific Title | Urinary nerve growth factor and brain-derived neurotrophic factor levels in children with lower urinary tract symptom |
| Date of disclosure of the study information | 2015/12/28 |
| Last modified on | 2018/07/05 17:48:30 |
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Basic information
Public title
Urinary nerve growth factor and brain-derived neurotrophic factor levels in children with lower urinary tract symptom
Acronym
Urinary NGF and BDNF in children with lower urinary tract symptom
Scientific Title
Urinary nerve growth factor and brain-derived neurotrophic factor levels in children with lower urinary tract symptom
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Katsuya Aoki |
Organization
Nara Medical University
Division name
Department of Urology
Zip code
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
aokik@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuya Aoki |
Organization
Nara Medical University
Division name
Department of Urology
Zip code
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
aokik@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2013 | Year | 09 | Month | 18 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023476
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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