UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017825 |
|---|---|
| Receipt number | R000020649 |
| Scientific Title | Efficacy of tamsulosin or tadalafil for voiding disorders in I-125 prostate seed implant patients |
| Date of disclosure of the study information | 2015/06/06 |
| Last modified on | 2022/06/11 16:38:26 |
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Basic information
Public title
Efficacy of tamsulosin or tadalafil for voiding disorders in I-125 prostate seed implant patients
Acronym
Medications for I-125 prostate seed implant patients
Scientific Title
Efficacy of tamsulosin or tadalafil for voiding disorders in I-125 prostate seed implant patients
Scientific Title:Acronym
Medications for I-125 prostate seed implant patients
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare efficacy of tamsulosin or tadalafil for voiding disorders in I-125 prostate seed implant patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
voiding parameters
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
tamsulosin
Interventions/Control_2
tadalafil
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
prostate cancer eligible for I125 seed implant
Key exclusion criteria
prostate cancer not eligible for I125 seed implant
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuichi Mizuno MD |
Organization
Keio university, school of medicine
Division name
Department of Urology
Zip code
Address
35 Shinanomachi, Shinjuku-ku
TEL
03-5363-3825
mizunor@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuichi Mizuno MD |
Organization
Keio university, school of medicine
Division name
Department of Urology
Zip code
Address
35 Shinanomachi, Shinjuku-ku
TEL
03-5363-3825
Homepage URL
mizunor@keio.jp
Sponsor or person
Institute
Department of Urology, Keio university, school of medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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 | 06 | Month | 06 | 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
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 03 | 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 | 06 | Month | 05 | Day |
Last modified on
| 2022 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020649
