UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022613 |
|---|---|
| Receipt number | 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 | 2020/12/08 13:58:34 |
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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
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
nakaiyasushi@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Department of Urology
Institute
Department
Personal name
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
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
218
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The results will be reported at ASTRO in 25th-28th October.
Date of the first journal publication of results
| 2020 | Year | 10 | Month | 25 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
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
| 2020 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026051
