UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037088 |
|---|---|
| Receipt number | R000042258 |
| Scientific Title | Comparison PVP with CVP |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2019/06/17 08:07:54 |
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Basic information
Public title
Comparison photoselective vaporization of the prostate (PVP) with contact laser vaporization of the prostate (CVP) for the benign prostatic hyperplasia (BPH)
Acronym
Analysis of the vaporization treatment for the BPH
Scientific Title
Comparison PVP with CVP
Scientific Title:Acronym
Analysis of the vaporization treatment for the BPH
Region
| Japan |
Condition
Condition
benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison the effect and safety of PVP and CVP for BPH
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Therapeutic effect of symptom and QOL(3,6,12,18 and month)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Treatment: PVP
Interventions/Control_2
Treatment: CVP
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
| 50 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male
Key inclusion criteria
IPSS>7
QOL>1
prostatic volume>30
Key exclusion criteria
prostate cancer
After surgery for BPH
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Seki |
| Middle name | |
| Last name | Narihito |
Organization
Kyushu Central Hospital of the Mutual Aid Association of Public Scholl Teachers
Division name
Department of Urology
Zip code
8158588
Address
Shiobaru3-13-1,Minami-ku, Fukuoka-city, Fukuoka, Japan
TEL
092-541-4936
narihito@kyushu-ctr-hsp.com
Public contact
Name of contact person
| 1st name | Dejima |
| Middle name | |
| Last name | Takashi |
Organization
Kyushu Central Hospital of the Mutual Aid Association of Public Scholl Teachers
Division name
Department of Urology
Zip code
8158588
Address
Shiobaru3-13-1,Minami-ku, Fukuoka-city, Fukuoka, Japan
TEL
092-541-4936
Homepage URL
dejima@uro.med.kyushu-uac.jp
Sponsor or person
Institute
Kyushu Central Hospital of the Mutual Aid Association of Public Scholl Teachers
Institute
Department
Personal name
Funding Source
Organization
Kyushu Central Hospital of the Mutual Aid Association of Public Scholl Teachers
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu Central Hospital of the Mutual Aid Association of Public Scholl Teachers
Address
Shiobaru3-13-1,Minami-ku, Fukuoka-city, Fukuoka, Japan
Tel
dejima@uro.med.kyushu-uac.jp
dejima@uro.med.kyushu-uac.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
| 2019 | Year | 07 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 17 | Day |
Last modified on
| 2019 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042258
