UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040287
Receipt number R000045965
Scientific Title The Impact of Microalbuminuria on Overactive Bladders: Results from a Community-Based Four-Year Longitudinal Study in Japan
Date of disclosure of the study information 2020/05/02
Last modified on 2020/05/01 20:00:22

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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 or person

Institute

Hirosaki University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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