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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022514
Receipt No. 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

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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
Email 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
Email inosyogo@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025951

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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