UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011734 |
|---|---|
| Receipt number | R000009317 |
| Scientific Title | Clinical evaluation of extracorporeal shockwave therapy in patients with erectile dysfunction |
| Date of disclosure of the study information | 2013/09/12 |
| Last modified on | 2019/07/29 20:30:11 |
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Basic information
Public title
Clinical evaluation of extracorporeal shockwave therapy in patients with erectile dysfunction
Acronym
Clinical evaluation of extracorporeal shockwave therapy in patients with erectile dysfunction
Scientific Title
Clinical evaluation of extracorporeal shockwave therapy in patients with erectile dysfunction
Scientific Title:Acronym
Clinical evaluation of extracorporeal shockwave therapy in patients with erectile dysfunction
Region
| Japan |
Condition
Condition
Erectile dysfunction
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of low-intensity extracorporeal shockwave therapy on men with erectile dysfunction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the erectile function by low-intensity extracorporeal shockwave therapy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Low-intensity extracorporeal shockwave therapy was applied to the penile shaft and crura.
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
| Not applicable |
Gender
Male
Key inclusion criteria
Men who was diagnosed with erectile dysfunction
Key exclusion criteria
Patients with endocrine, mental or psychologic disease caused of erectile dysfuction
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Matsubara |
Organization
Hiroshima University School of Medicine
Division name
Urology
Zip code
7348551
Address
1-2-3 Kasumi, Minami-ku, Hirosima city
TEL
082-257-5242
matsua@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Inoue |
Organization
Hiroshima University School of Medicine
Division name
Urology
Zip code
7348551
Address
1-2-3 Kasumi, Minami-ku, Hirosima city
TEL
082-257-5242
Homepage URL
inosyogo@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University School of Medicine Department of Urology
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University Hospital, Center for Integrated Medical Research
Address
1-2-3 Kasumi, Minami-ku, Hirosima city
Tel
082-257-1725
protocol@cimr.hiroshima-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
| 2013 | Year | 09 | Month | 12 | 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
Completed
Date of protocol fixation
| 2012 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2012 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 12 | Day |
Last modified on
| 2019 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009317
