UMIN-CTR Clinical Trial

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 Yoshinori Middle name Last name Tanaka
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 Tanaka
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
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	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 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	70
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 06 Month 18 Day
Last follow-up date	2020 Year 06 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 04 Month 03 Day
Last modified on	2020 Year 06 Month 16 Day

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