UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019735 |
|---|---|
| Receipt number | 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 09:32:07 |
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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
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
tsuru@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Urology, Shiga University of medical Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022668
