UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051079 |
|---|---|
| Receipt number | R000058248 |
| Scientific Title | Investigation of the Relationship between Lower Urinary Tract Symptoms and General Condition of nursing home Residents |
| Date of disclosure of the study information | 2023/05/17 |
| Last modified on | 2023/11/16 16:35:46 |
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Basic information
Public title
Investigation of the Relationship between Lower Urinary Tract Symptoms and General Condition of nursing home Residents
Acronym
Investigation of the Relationship between Lower Urinary Tract Symptoms and General Condition of nursing home Residents
Scientific Title
Investigation of the Relationship between Lower Urinary Tract Symptoms and General Condition of nursing home Residents
Scientific Title:Acronym
Investigation of the Relationship between Lower Urinary Tract Symptoms and General Condition of nursing home Residents
Region
| Japan |
Condition
Condition
Lower urinary tract symptoms
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate systemic conditions such as lower urinary tract symptoms, medications, and frailty in nursing home residents and how they affect each other.
Basic objectives2
Others
Basic objectives -Others
Effects of drugs on frailty, association between frailty and lower urinary tract symptoms
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effects of medications being taken on lower urinary tract 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Nursing home residents
Key exclusion criteria
(1) difficulty in measuring residual urine volume by ultrasound, (2) difficulty in answering various questions, (3) significant cognitive decline to the point of being unable to follow instructions
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yoshinaga |
| Middle name | |
| Last name | Okumura |
Organization
University of Fukui
Division name
Department of Urology
Zip code
9101193
Address
23-3, Matsuoka shimoaizuki, Eiheiji-cho, Yoshiga-gun, Fukui
TEL
0776618174
urokumura@gmail.com
Public contact
Name of contact person
| 1st name | Yoshinaga |
| Middle name | |
| Last name | Okumura |
Organization
University of Fukui
Division name
Department of urology
Zip code
9101193
Address
23-3, Matsuoka shimoaizuki, Eiheiji-cho, Yoshiga-gun, Fukui
TEL
0776618174
Homepage URL
urokumura@gmail.com
Sponsor or person
Institute
Department of urology, university of Fukui
Institute
Department
Personal name
Yoshinaga Okumura
Funding Source
Organization
Nothing to disclosure
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of University of Fukui
Address
23-3, Matsuoka shimoaizuki, Eiheiji-cho, Yoshiga-gun, Fukui
Tel
0776618174
rinsho-rinri@ml.u-fukui.ac.jp
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
| 2023 | Year | 05 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 09 | Month | 30 | Day |
Other
Other related information
Urinary function will be assessed through a voiding diary and bladder capacity measurement using a bladder ultrasound imaging device (Lilliam). The ACB score, which evaluates the effect of anticholinergic medication on urinary function on a 3-point scale, and the JCHS, which evaluates frailty, will be used to determine how they are related to lower urinary tract symptoms.
Management information
Registered date
| 2023 | Year | 05 | Month | 17 | Day |
Last modified on
| 2023 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058248
| 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 |
