UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004939 |
|---|---|
| Receipt number | R000005696 |
| Scientific Title | Ambulatory voiding in the elderly based on functional assessment |
| Date of disclosure of the study information | 2011/01/24 |
| Last modified on | 2016/07/29 14:15:13 |
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Basic information
Public title
Ambulatory voiding in the elderly based on functional assessment
Acronym
Ambulatory voiding in the elderly
Scientific Title
Ambulatory voiding in the elderly based on functional assessment
Scientific Title:Acronym
Ambulatory voiding in the elderly
Region
| Japan |
Condition
Condition
Urinary incontinence
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Objective of this study is to improve the quality of life of caregivers and elderly people who usually use diapers for urinary incontinence based on functional assessment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Quality of life of elderly people and caregivers.
Key secondary outcomes
Change of quantity and cost of diaper.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Functional analysis of voiding for elderly people.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Elderly people living in a nursing house.
Key exclusion criteria
Elderly people with following conditions; a severe disease, terminal phase, coma, or acute phase.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukio Homma |
Organization
Graduate school of Medicine, the University of Tokyo
Division name
Department of Urology
Zip code
Address
7-3-1 Hongo Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-5800-8753
homma-uro@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motofumi Suzuki |
Organization
Graduate school of Medicine, the University of Tokyo
Division name
Department of Urology
Zip code
Address
7-3-1 Hongo Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-5800-8753
Homepage URL
http://www.ristex.jp/implementation/index.html
suzukim-uro@h.u-tokyo.ac.jp
Sponsor or person
Institute
Department of Urology, Graduate school of Medicine, the University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Koyama healthcare group
Name of secondary funder(s)
Megumi Long-Term Care Health Facility
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
株式会社日本ライフデザイン（東京都）
社会福祉法人草加福祉会（埼玉県）
社会福祉法人カメリア会（東京都）
社会福祉法人湖成会（静岡県）
医療法人社団湖聖会（千葉県）
社会福祉法人苗場福祉会（新潟県）
介護老人保健施設めぐみ（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 24 | Day |
Related information
URL releasing protocol
http://www.ristex.jp/implementation/development/22elderly.html
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/27399836
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
| 2010 | Year | 11 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 24 | Day |
Last modified on
| 2016 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005696
| 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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| Registered date | File name |
