UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032767
Receipt number R000037382
Scientific Title Effects of tadalafil on frequency/volume chart in treatment-naive patients with benign prostatic hyperplasia in the real-world clinical setting
Date of disclosure of the study information 2018/06/01
Last modified on 2020/05/17 23:24:47

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Basic information

Public title

Effects of tadalafil on frequency/volume chart in treatment-naive patients with benign prostatic hyperplasia in the real-world clinical setting

Acronym

Effects of tadalafil on frequency/volume chart

Scientific Title

Effects of tadalafil on frequency/volume chart in treatment-naive patients with benign prostatic hyperplasia in the real-world clinical setting

Scientific Title:Acronym

Effects of tadalafil on frequency/volume chart

Region

Japan


Condition

Condition

Benign prostatic hyperplasia

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of tadalafil on frequency/volume chart in patients with benign prostatic hyperplasia

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

change of the number of voids

Key secondary outcomes

change of mean voided volume


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

50 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

treatment-naive patients with benign prostatic hyperplasia who have the international prostate symptom score of eight points or greater

Key exclusion criteria

urinary tract infection, acute urinary retention, prostate cancer, neurogenic bladder, the use of an alpha-1 adrenoceptor antagonist or anti-androgen, and a history of prostatic surgery

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yoshinori
Middle name
Last name Yoshinori

Organization

Hokkaido Prefectural Esashi Hospital

Division name

Division of Urology

Zip code

043-0022

Address

484, Fushikido-cho, Esashi-cho, Hiyama-gun, Hokkaido 043-0022, Japan

TEL

0139-52-0036

Email

rinoshiyokanata@me.com


Public contact

Name of contact person

1st name Yoshinori
Middle name
Last name Yoshinori

Organization

Hokkaido Prefectural Esashi Hospital

Division name

Division of Urology

Zip code

043-0022

Address

484, Fushikido-cho, Esashi-cho, Hiyama-gun, Hokkaido 043-0022, Japan

TEL

0139-52-0036

Homepage URL


Email

rinoshiyokanata@me.com


Sponsor or person

Institute

Hokkaido Prefectural Esashi Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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

Ethics Committee of Hokkaido Prefectural Esashi Hospital

Address

484, Fushikido-cho, Esashi-cho, Hiyama-gun, Hokkaido 043-0022, Japan

Tel

0139-52-0036

Email

hofuku.esabyo2@pref.hokkaido.jg.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

2018 Year 06 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

113

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

2014 Year 09 Month 26 Day

Date of IRB

2014 Year 09 Month 26 Day

Anticipated trial start date

2015 Year 05 Month 11 Day

Last follow-up date

2020 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2018 Year 05 Month 29 Day

Last modified on

2020 Year 05 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037382


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name