UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022514 |
|---|---|
| Receipt number | R000025951 |
| Scientific Title | Single arm open-label study to evaluate efficacy and safety of low intensity extracorporeal shockwave therapy in prostate cancer patients with ED after radical prostatectomy |
| Date of disclosure of the study information | 2016/06/06 |
| Last modified on | 2019/07/29 20:31:14 |
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Basic information
Public title
Single arm open-label study to evaluate efficacy and safety of low intensity extracorporeal shockwave therapy in prostate cancer patients with ED after radical prostatectomy
Acronym
Study to evaluate efficacy and safety of low intensity extracorporeal shockwave therapy in patients with ED after radical prostatectomy
Scientific Title
Single arm open-label study to evaluate efficacy and safety of low intensity extracorporeal shockwave therapy in prostate cancer patients with ED after radical prostatectomy
Scientific Title:Acronym
Study to evaluate efficacy and safety of low intensity extracorporeal shockwave therapy in patients with ED after radical prostatectomy
Region
| Japan |
Condition
Condition
Erectile dysfunction
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of low intensity extracorporeal shockwave therapy in patients with ED after radical prostatectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess efficacy of low intensity extracorporeal shockwave therapy
Key secondary outcomes
To assess safety of low intensity extracorporeal shockwave therapy
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.The duration of each low intensity extracorporeal shockwave therapy session was approximately 20 min, and each session comprised 300 shocks per treatment point (1500 per session) at an energy density of 0.09 mJ/mm2 and a frequency of 120/min. This therapy was performed nine times within the 90 days.
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
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
1) Prostate cancer patient is planned to the operation of radical prostatectomy.
2) Patient who is from 40 to 80 years old.
3) Patient had stable partnership of sexual intercourse over the three months until the radical prostatectomy.
4) Patient had the written consent of this study.
Key exclusion criteria
1) Patient with spinal injury, chronic blood disease, and anatomic anomaly of penile vessels.
2) Patient with endocrine, mental or psychologic disease caused of erectile dysfunction.
3) Patients with past history of ischemic heart disease, cerebral hemorrhage, cerebral infarction and fetal arrhythmia, or who can not withdraw hemagogic drugs such as aspirin and warfarin.
4) Patients with cardiovascular disease prohibited to the sexual intercourse.
5) Patients have sexually transmitted infection and penile abscess.
6) Patients using nitrate drugs such as Nitroglycerin.
7) Patients judged not to appropriate to this study by the doctor in charge of this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Matsubara |
Organization
Hiroshima University Hospital
Division name
Urology
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5242
matsua@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shogo Inoue |
Organization
Hiroshima University Hospital
Division name
Urology
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5242
Homepage URL
inosyogo@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
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
Address
Tel
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
| 2016 | Year | 06 | Month | 06 | 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
| 2016 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 29 | 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=R000025951
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| Registered date | File name |
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