UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022424 |
|---|---|
| Receipt number | R000025686 |
| Scientific Title | Comparison of brain active site of normal and overactive bladder, under the condition of bladder filling |
| Date of disclosure of the study information | 2016/05/24 |
| Last modified on | 2016/05/25 19:04:04 |
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Basic information
Public title
Comparison of brain active site of normal and overactive bladder, under the condition of bladder filling
Acronym
Comparison of brain active site of normal and overactive bladder, under the condition of bladder filling
Scientific Title
Comparison of brain active site of normal and overactive bladder, under the condition of bladder filling
Scientific Title:Acronym
Comparison of brain active site of normal and overactive bladder, under the condition of bladder filling
Region
| Japan |
Condition
Condition
Overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By using functional magnetic resonance imaging(fMRI), we examine whether the active sites of the brain at bladder filling is different from healthy controls in overactive bladder patients.
Basic objectives2
Others
Basic objectives -Others
Inquisitive study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The brain activation abnormality sites of overactive patients in comparison with healthy controls in fMRI.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
fMRI scanning to perform under the task.
The subject receives fMRI scanning in two different protocols one by one on a different day. And he(or she) receives approximately 320 scans(about 1 hour) in each protocol.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy controls
Healthy adult(more than 20 years old) volunteers they have no or mild overactive bladder symptoms(overactive bladder symptoms scores <6 points :the perfect score is 15 points).
Overactive bladder patients
Patients(more than 20 years old) with diagnosed overactive bladder, and they have medium or serious overactive bladder symptoms(OABSS is more than 6 points).
Key exclusion criteria
Subjects who have neurological or psychiatric disease,symptoms of urinary tract infection, or any other problems that precluded being scanned.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | OSAMU UKIMURA |
Organization
Kyoto Prefectural University of Medicine
Division name
Urology
Zip code
Address
465 kaji-cho, Kamigyo-ku Kyoto, Japan, 602-8566
TEL
075-251-5595
ukimura@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | NARUHIRO KAYUKAWA |
Organization
Kyoto Prefectural University of Medicine
Division name
Urology
Zip code
Address
465 kaji-cho, Kamigyo-ku Kyoto, Japan, 602-8566
TEL
075-251-5595
Homepage URL
nkayu@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
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
| 2016 | Year | 05 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 23 | Day |
Last modified on
| 2016 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025686
