UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006856 |
|---|---|
| Receipt number | R000008108 |
| Scientific Title | Clinical survey of urinary symptoms in stroke outpatients |
| Date of disclosure of the study information | 2011/12/07 |
| Last modified on | 2012/06/07 14:48:11 |
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Basic information
Public title
Clinical survey of urinary symptoms
in stroke outpatients
Acronym
Clinical survey of urinary symptoms
in stroke outpatients
Scientific Title
Clinical survey of urinary symptoms
in stroke outpatients
Scientific Title:Acronym
Clinical survey of urinary symptoms
in stroke outpatients
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This survey is conducted to investigate the conditions and the awareness of urinary symptoms in outpatients with stroke and to show the influence of urination trouble on patient's QOL.
Basic objectives2
Others
Basic objectives -Others
Urinary symptoms
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
# Urinary symptoms (OABSS, ICIQ-SF, IPSS)
# QOL (SF-8)
# Patient preference for urination treatment
# Relation between urinary symptoms and QOL
# Relation between subjective and objective urinary symptoms
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) 20 years old or older
(2) Sex: male and female
(3) Outpatient
(4) Patients who can response to the questionnaire
Key exclusion criteria
(1) Patients who can't consent to participate by themselves or patients without consent
(2) Cases who are regarded as inadequate for study enrollment by the investigator
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Itoh |
Organization
Keio University School of Medicine
Division name
Department of Neurology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University School of Medicine
Division name
Department of Neurology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Neurology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Neurology, Keio University School 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
慶應義塾大学病院(東京都) Keio University Hospital(Tokyo)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 07 | 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
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Stroke subtype, ADL assessment, Neurological findings, Imaging, Medicine, Blood test
Management information
Registered date
| 2011 | Year | 12 | Month | 07 | Day |
Last modified on
| 2012 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008108
