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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033750
Receipt No. R000038498
Scientific Title The correlation between a severity of lower urinary tract symptoms and adipocytokines concentrations
Date of disclosure of the study information 2018/11/01
Last modified on 2018/08/14

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Basic information
Public title The correlation between a severity of lower urinary tract symptoms and adipocytokines concentrations
Acronym The correlation between a severity of lower urinary tract symptoms and adipocytokines concentrations
Scientific Title The correlation between a severity of lower urinary tract symptoms and adipocytokines concentrations
Scientific Title:Acronym The correlation between a severity of lower urinary tract symptoms and adipocytokines concentrations
Region
Japan

Condition
Condition patinets with lower urinary tract symptoms, including benign prostatic hyperplasia and overactive bladder
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To invesitigate the correlation between a severity of lower urinary tract symptoms and adipocytokines concentrations
Basic objectives2 Others
Basic objectives -Others Change in the level of adipocytokines concentrations during the treatment of lower urinary tract symptoms
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the correlation between a severity of lower urinary tract symptoms and adipocytokines concentrations
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
40 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria patients who visited our hospital with a chief complaint of lower urinary tract symptoms
Key exclusion criteria Medical conditions for exclusion were neurogenic bladder dysfunction, bladder calculi, active urinary tract infection, severe cardiac disease, renal dysfunction (serum creatinine level more than 5 mg/dL), and/or hepatic dysfunction (Child-Pugh level more than 10 points).
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihisa Matsukawa
Organization Nagoya University Graduate School of Medicine
Division name Department of Urology
Zip code
Address 65, tsurumai, Showa-ku, nagoya, Japan
TEL 052-744-2985
Email yoshi44@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihisa Matsukawa
Organization Nagoya University Graduate School of Medicine
Division name Department of Urology
Zip code
Address 65, tsurumai, Showa-ku, nagoya, Japan
TEL 052-744-2985
Homepage URL
Email yoshi44@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
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
2018 Year 11 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
2018 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 12 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 none

Management information
Registered date
2018 Year 08 Month 14 Day
Last modified on
2018 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038498

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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