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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019735
Receipt No. R000022668
Scientific Title Examination the efficacy of Mirabegron on patient with overactive bladder after treatment with a1 blocker for benign prostatic hyperplasia
Date of disclosure of the study information 2015/11/10
Last modified on 2020/05/29

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Basic information
Public title Examination the efficacy of Mirabegron on patient with overactive bladder after treatment with a1 blocker for benign prostatic hyperplasia
Acronym Examination the efficacy of Mirabegron on patient with a1 blocker resistance overactive bladder
Scientific Title Examination the efficacy of Mirabegron on patient with overactive bladder after treatment with a1 blocker for benign prostatic hyperplasia
Scientific Title:Acronym Examination the efficacy of Mirabegron on patient with a1 blocker resistance overactive bladder
Region
Japan

Condition
Condition Overactive bladder
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 the examination on efficacy of Mirabegron
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes OABSS after twelve weeks
Key secondary outcomes IPSS

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 prescribe Mirabegron for 12 weeks
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Overactive bladder after treatment of BPH
Key exclusion criteria suspect of malignancy
contraindication of Mirabegron
using other anticholinergic agent
using A1 blocker within 4 weeks
using Dutasteride
redidual urine over 50mL
urinary infection
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Akihiro
Middle name
Last name Kawauchi
Organization Shiga University of medical Science
Division name Urology
Zip code 5202192
Address Setatsukinowacho Otsu Shiga
TEL 0775482273
Email tsuru@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name Teruhiko
Middle name
Last name Tsuru
Organization Shiga University of medical Science
Division name Urology
Zip code 5202192
Address Setatsukinowacho Otsu Shiga
TEL 0775482273
Homepage URL
Email tsuru@belle.shiga-med.ac.jp

Sponsor
Institute Department of Urology, Shiga University of medical Science
Institute
Department

Funding Source
Organization Department of Urology, Shiga University of medical Science
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 Department of Urology, Shiga University of medical Science
Address Setatsukinowacho Otsu Shiga
Tel 0775482273
Email tsuru-sig@umin.ac.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
2015 Year 11 Month 10 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 20
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 11 Month 25 Day
Date of IRB
2014 Year 11 Month 25 Day
Anticipated trial start date
2015 Year 11 Month 09 Day
Last follow-up date
2025 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
2015 Year 11 Month 10 Day
Last modified on
2020 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022668

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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