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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022613
Receipt No. R000026051
Scientific Title Efficacy of mirabegron for voiding disorders in patient who underwent prostate low-dose-rate brachytherapy
Date of disclosure of the study information 2016/07/01
Last modified on 2019/07/14

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Basic information
Public title Efficacy of mirabegron for voiding disorders in patient who underwent prostate low-dose-rate brachytherapy
Acronym Efficacy of mirabegron in patient treathed with brachytherapy
Scientific Title Efficacy of mirabegron for voiding disorders in patient who underwent prostate low-dose-rate brachytherapy
Scientific Title:Acronym Efficacy of mirabegron in patient treathed with brachytherapy
Region
Japan

Condition
Condition prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy for voiding disorder in patients who underwent low-dose-rate brachytherapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the change from baseline to three months later after brachytherapy in mean volume voided per micturition
Key secondary outcomes the change from baseline to three months later after brachytherapy in IPSS,OABSS, and EPIC
the change from baseline to three months later after brachytherapy in maximum urinary flow rate, residual urine volume, and mean number of micturitions per 24 hours.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatments were administered once daily (tamsrosin 0.2mg) during 12 months after low-dose-rate brachytherapy
Interventions/Control_2 Treatments were administered once daily (mirabegron 50mg) during 3 months after low-dose-rate brachytherapy
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
85 years-old >=
Gender Male
Key inclusion criteria patients who underwent low-dose-rate brachytherapy
Key exclusion criteria considered unsuitable for the trial by doctors
residual urine volume greater than 100 ml
Qmax less than 5 ml per second
contraindicated to medication with mirabegron
history of urinary retention
performance of clean intermittent catheterization
Target sample size 240

Research contact person
Name of lead principal investigator
1st name Yasushi
Middle name
Last name Nakai
Organization Nara Medical University
Division name Department of Urology
Zip code 6348522
Address 840 Shijo-cho, Kashihara-shi, Nara, Japan
TEL 0744-22-3051
Email nakaiyasushi@naramed-u.ac.jp

Public contact
Name of contact person
1st name Yasushi
Middle name
Last name Nakai
Organization Nara Medical University
Division name Department of Urology
Zip code 6348522
Address 840 Shijo-cho, Kashihara-shi, Nara, Japan
TEL 0744-22-3051
Homepage URL
Email nakaiyasushi@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Department of Urology
Institute
Department

Funding Source
Organization None
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 Nara Medical University
Address 840 Shijyocho Kashihara Nara
Tel 0744-22-3051
Email nakaiyasushi@naramed-u.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
2016 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 Enrolling by invitation
Date of protocol fixation
2016 Year 06 Month 20 Day
Date of IRB
2016 Year 08 Month 17 Day
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2018 Year 12 Month 03 Day
Date of closure to data entry
2018 Year 12 Month 26 Day
Date trial data considered complete
2018 Year 12 Month 26 Day
Date analysis concluded
2019 Year 07 Month 14 Day

Other
Other related information

Management information
Registered date
2016 Year 06 Month 05 Day
Last modified on
2019 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026051

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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