UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039261 |
|---|---|
| Receipt number | 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 | 2021/07/31 16:26:09 |
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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
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
masatos@juntendo-urayasu.jp
Sponsor or person
Institute
Juntendo University Urayasu Hospital
Institute
Department
Personal name
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
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
20
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
Completed
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 | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044776
