UMIN-CTR Clinical Trial

Basic information
Public title	The Impact of Microalbuminuria on Overactive Bladders: Results from a Community-Based Four-Year Longitudinal Study in Japan
Acronym	The Impact of Microalbuminuria on Overactive Bladders: Results from a Community-Based Four-Year Longitudinal Study in Japan
Scientific Title	The Impact of Microalbuminuria on Overactive Bladders: Results from a Community-Based Four-Year Longitudinal Study in Japan
Scientific Title:Acronym	The Impact of Microalbuminuria on Overactive Bladders: Results from a Community-Based Four-Year Longitudinal Study in Japan
Region	Japan

Condition
Condition	Overactive bladder
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the longitudinal association of microalbuminuria on overactive bladder (OAB).
Basic objectives2	Others
Basic objectives -Others	To investigate the longitudinal association of microalbuminuria on overactive bladder (OAB).
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To investigate the longitudinal association of microalbuminuria on overactive bladder (OAB).
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	This longitudinal study investigated 561 participants of the Iwaki Health Promotion Project in both 2015 and 2019 in Japan.
Key exclusion criteria	Other than above
Target sample size	561

Research contact person
Name of lead principal investigator	1st name Shingo Middle name Last name Hatakeyama
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Urology
Zip code	036-8562
Address	5 Zaifu-chou, Hirosaki, Aomori, Japan
TEL	0172-39-5091
Email	shingoh@hirosaki-u.ac.jp

Public contact
Name of contact person	1st name shingo Middle name Last name Hatakeyama
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Urology
Zip code	036-8562
Address	5 Zaifu-chou, Hirosaki, Aomori, Japan
TEL	0172-39-5091
Homepage URL
Email	shingoh@hirosaki-u.ac.jp

Sponsor
Institute	Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization	The Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Hirosaki University Graduate School of Medicine
Address	5 Zaifu-chou, Hirosaki, Aomori, Japan
Tel	0172-39-5091
Email	rinri@hirosaki-u.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	2020 Year 05 Month 02 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	561
Results	Microalbuminuria may be an independent risk indicator for OAB symptoms exacerbation.
Results date posted	2020 Year 05 Month 01 Day
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	2020 Year 03 Month 01 Day
Date of IRB	2018 Year 03 Month 01 Day
Anticipated trial start date	2020 Year 03 Month 01 Day
Last follow-up date	2020 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To investigate the longitudinal association of microalbuminuria on overactive bladder (OAB), this longitudinal study investigated 561 participants of the Iwaki Health Promotion Project in both 2015 and 2019.

Management information
Registered date	2020 Year 05 Month 01 Day
Last modified on	2020 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045965

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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