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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028546
Receipt No. R000032672
Scientific Title A observational study of the impact of frailty on lower urinary tract symptoms in community-dwelling population
Date of disclosure of the study information 2017/08/09
Last modified on 2017/08/05

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Basic information
Public title A observational study of the impact of frailty on lower urinary tract symptoms in community-dwelling population
Acronym A observational study of the impact of frailty on lower urinary tract symptoms in community-dwelling population
Scientific Title A observational study of the impact of frailty on lower urinary tract symptoms in community-dwelling population
Scientific Title:Acronym A observational study of the impact of frailty on lower urinary tract symptoms in community-dwelling population
Region
Japan

Condition
Condition Lower urinary tract symptoms (LUTS)
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the impact of frailty on lower urinary tract symptoms in community-dwelling population.
Basic objectives2 Others
Basic objectives -Others relationship
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Relationship between frailty and lower urinary tract symptoms (LUTS) using International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS) and frailty assessment tools such as G8 and/or Frailty Discriminant score
Key secondary outcomes IPSS sub-score and frailty
OABSS sub-score and frailty
Relationship between frailty and oxidative stress, and LUTS

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
100 years-old >=
Gender Male and Female
Key inclusion criteria Subjects who participant in the Iwaki health promotion project after 2006
Key exclusion criteria Subjects who could not evaluate lower urinary tract symptoms.
Target sample size 4000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo Hataeyama
Organization Hirosaki University Graduate School of Medicine
Division name Urology
Zip code
Address 5 Zaifu-chou
TEL 0172395091
Email shingorilla2@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Hatakeyama
Organization Hirosaki University Graduate School of Medicine
Division name Urology
Zip code
Address 5 Zaifu-chou
TEL 0172395091
Homepage URL
Email shingorilla2@gmail.com

Sponsor
Institute Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 08 Month 09 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
2017 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is retrospective/prospective study of the impact of frailty on lower urinary tract symptoms in community-dwelling population. Patients in this study undergo frailty assessment including gait speed, handgrip strength, fatigue and depression questionnaire, and basic blood biochemical test. Frailty Discriminant score were calculated, and outcomes are evaluated.

Management information
Registered date
2017 Year 08 Month 05 Day
Last modified on
2017 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032672

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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