UMIN-CTR Clinical Trial

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