UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035551 |
|---|---|
| Receipt number | R000040453 |
| Scientific Title | Prospective study on the relationship between frailty and detrusor underactivity |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2019/01/15 18:26:02 |
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Basic information
Public title
Prospective study on the relationship between frailty and detrusor underactivity
Acronym
Frailty and detrusor underactivity
Scientific Title
Prospective study on the relationship between frailty and detrusor underactivity
Scientific Title:Acronym
Frailty and detrusor underactivity
Region
| Japan |
Condition
Condition
Frailty
Classification by specialty
| Geriatrics | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of frailty on bladder function.
Basic objectives2
Others
Basic objectives -Others
To investigate whether prevention or treamtment of frailty affects bladder function
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between frailty and detrusor contractility
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Rehabilitation and nutritional guidance for frailty
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
a) patients having lower urinary tract symptoms
b) patients who can visit the hospital on foot
c) patietns with 5 out of 6 items in Kats Index showing "independent" and Frailty index showing 2 or more points.
d) patients who understand the study and provide written informed consent.
Key exclusion criteria
a) quadriplegic patients
b) patients who were diagnosed as demetia or treated with anti-dementia drug.
c) patients in a condition of need for long-term care (primary nursing care requirement authorization category 1-5)
d) patients with neurological diseases or spine disorders
e) patients who underwent pelvic surgeries
f) patients who are not suitable for body composition meter (BCI)
g) patients who are not capable of providing written informed consent
h) patients who are considered to be unsuitable for the study by primary doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Majima |
Organization
Nagoya University Graduate School of Medicine
Division name
Urology
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi-ken
TEL
0527442984
majima@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Majima |
Organization
Nagoya University Graduate School of Medicine
Division name
Urology
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi-ken
TEL
0527442984
Homepage URL
majima@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate 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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 01 | 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
| 2019 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | 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
| 2019 | Year | 01 | Month | 15 | Day |
Last modified on
| 2019 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040453
| 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 |
