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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name