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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039261
Receipt No. R000044776
Scientific Title The observational study for penile blood flow and sexual questionnaire.
Date of disclosure of the study information 2020/01/26
Last modified on 2021/04/05

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Basic information
Public title The observational study for penile blood flow and sexual questionnaire.
Acronym The observational study for penile blood flow and sexual questionnaire.
Scientific Title The observational study for penile blood flow and sexual questionnaire.
Scientific Title:Acronym The observational study for penile blood flow and sexual questionnaire.
Region
Japan

Condition
Condition Erectile Dysfunction
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The penile blood flow measurement using laser blood flowmetry, and its correlation with sexual questionnaire
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The penile blood flow measurement
Key secondary outcomes The correlation between laser blood flowmetry, and sexual questionnaire

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
Key inclusion criteria complaint of Erectile Dysfunction
Key exclusion criteria The doctor deemed inappropriate patient for this study.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Masato
Middle name
Last name Shirai
Organization Juntendo University Urayasu Hospital
Division name Urology
Zip code 2790021
Address 2-1-1, Tomioka, Urayasu, Chiba, Japan
TEL 0473533111
Email masatos@juntendo-urayasu.jp

Public contact
Name of contact person
1st name Masato
Middle name Shirai
Last name Shirai
Organization Juntendo University Urayasu Hospital
Division name Urology
Zip code 2790021
Address 2-1-1, Tomioka, Urayasu, Chiba, Japan
TEL 0473533111
Homepage URL
Email masatos@juntendo-urayasu.jp

Sponsor
Institute Juntendo University Urayasu Hospital
Institute
Department

Funding Source
Organization Department of Urology, Juntendo University Urayasu Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Men's health clinic Tokyo
Name of secondary funder(s)

IRB Contact (For public release)
Organization Juntendo University Urayasu Hospital
Address 2-1-1, Tomioka, Urayasu, Chiba, Japan
Tel +81473533111
Email rinri-urayasu@juntendo-urayasu.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 順天堂大学医学部附属浦安病院

Other administrative information
Date of disclosure of the study information
2020 Year 01 Month 26 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 No longer recruiting
Date of protocol fixation
2019 Year 05 Month 18 Day
Date of IRB
2019 Year 05 Month 21 Day
Anticipated trial start date
2019 Year 05 Month 21 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 06 Month 30 Day

Other
Other related information The observational study for penile blood flow and sexual questionnaire.

Management information
Registered date
2020 Year 01 Month 26 Day
Last modified on
2021 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044776

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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