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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032082
Receipt No. R000036601
Scientific Title Long-term effect of dutasteride as add-on therapy for benign prostatic hyperplasia with persistent overactive bladder symptoms after treatment of alpha-1 blocker
Date of disclosure of the study information 2018/04/04
Last modified on 2018/04/03

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Basic information
Public title Long-term effect of dutasteride as add-on therapy for benign prostatic hyperplasia with persistent overactive bladder symptoms after treatment of alpha-1 blocker
Acronym Dutasteride as add-on therapy for overactive bladder symptoms
Scientific Title Long-term effect of dutasteride as add-on therapy for benign prostatic hyperplasia with persistent overactive bladder symptoms after treatment of alpha-1 blocker
Scientific Title:Acronym Dutasteride as add-on therapy for overactive bladder symptoms
Region
Japan

Condition
Condition Benign prostatic hyperplasia
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The long-term effect of dutasteride as add-on therapy for benign prostatic hyperplasia with persistent overactive bladder symptoms after treatment of alpha-1 blocker is evaluated
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overactive bladder symptom score
Key secondary outcomes

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 Patients with benign prostatic hyperplasia who have overactive bladder symptom score of three points or higher after treatment of alpha-1 blocker for more than one year
Key exclusion criteria Use of antimuscarinic drug, beta-3 adrenergic agonist or antiandrogen drug
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinori Tanaka
Organization Hokkaido Prefectural Esashi Hospital
Division name Division of Urology
Zip code
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
Middle name
Last name Yoshinori Tanaka
Organization Hokkaido Prefectural Esashi Hospital
Division name Division of Urology
Zip code
Address 484, Fushikido-cho, Esashi-cho, Hiyama-gun, Hokkaido 043-0022, Japan
TEL 0139-52-0036
Homepage URL
Email rinoshiyokanata@me.com

Sponsor
Institute Hokkaido Prefectural Esashi Hospital
Institute
Department

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
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
2018 Year 04 Month 04 Day

Related information
URL releasing protocol
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
2014 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 18 Day
Last follow-up date
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 04 Month 03 Day
Last modified on
2018 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036601

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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