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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | prostate cancer | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 240 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |