UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027612 |
|---|---|
| Receipt number | R000031642 |
| Scientific Title | A prospective study of preventive effect of tadalafil on urethral stricture after transurethral surgery |
| Date of disclosure of the study information | 2017/06/05 |
| Last modified on | 2021/06/06 00:34:58 |
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Basic information
Public title
A prospective study of preventive effect of tadalafil on urethral stricture after transurethral surgery
Acronym
Preventive effect of tadalafil on urethral stricture after transurethral surgery
Scientific Title
A prospective study of preventive effect of tadalafil on urethral stricture after transurethral surgery
Scientific Title:Acronym
Preventive effect of tadalafil on urethral stricture after transurethral surgery
Region
| Japan |
Condition
Condition
urethral stricture
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine preventive effect of tadalafil on urethral stricture after transurethral surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Frequency of urethral stricture
Key secondary outcomes
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 considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
tadarafil 5mg per day orally
Interventions/Control_2
no medication
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Male patients receiving transurethral surgery
Key exclusion criteria
NO user, allergy to tadalafil and ischemic heart disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Matsushima |
Organization
Tokyo Metropolitan Police Hospital
Division name
Department of Urology
Zip code
164-0001
Address
4-22-1, Nakano, Nakano-ku, Tokyo, Japan
TEL
03-5343-5611
hmatsu53@me.com
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Matsushima |
Organization
Tokyo Metropolitan Police Hospital
Division name
Department of Urology
Zip code
164-0001
Address
4-22-1, Nakano, Nakano-ku, Tokyo, Japan
TEL
03-5343-5611
Homepage URL
http://www.keisatsubyoin.or.jp/research.html
yakuzai@keisatsubyoin.or.jp
Sponsor or person
Institute
Hisashi Matsushima
Tokyo Metropolitan Police Hospital
Department of Urology
Institute
Department
Personal name
Funding Source
Organization
Hisashi Matsushima
Tokyo Metropolitan Police Hospital
Department of Urology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
An Institutional Review Board in TMPH
Address
4-22-1, Nakano, Nakano-ku, Tokyo, Japan
Tel
03-5343-5611
yakuzai@keisatsubyoin.or.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
| 2017 | Year | 06 | Month | 05 | Day |
Related information
URL releasing protocol
http://www.keisatsubyoin.or.jp/research.html
Publication of results
Unpublished
Result
URL related to results and publications
http://www.keisatsubyoin.or.jp/research.html
Number of participants that the trial has enrolled
60
Results
Under investigation
Results date posted
| 2021 | Year | 06 | Month | 06 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Preparing to submit
Date of the first journal publication of results
Baseline Characteristics
Patients receiving transurethral surgery for BPH
Participant flow
Finished
Adverse events
Nothing
Outcome measures
Risk factor of urethral stricture
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 02 | Day |
Last modified on
| 2021 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031642
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
