UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017925 |
|---|---|
| Receipt number | R000020444 |
| Scientific Title | The Efficacy of tadarafili for Bladder outlet obstruction and storage function: prospective urodynamic study |
| Date of disclosure of the study information | 2015/06/25 |
| Last modified on | 2017/01/21 11:56:54 |
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Basic information
Public title
The Efficacy of tadarafili for Bladder outlet obstruction and storage function: prospective urodynamic study
Acronym
UDS trial of tadarafili
Scientific Title
The Efficacy of tadarafili for Bladder outlet obstruction and storage function: prospective urodynamic study
Scientific Title:Acronym
UDS trial of tadarafili
Region
| Japan |
Condition
Condition
benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
urodynamic evaluation of tadarafili
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
The change of bladder outlet obstruction and storage function
Key secondary outcomes
The change of subjective parameters
Base
Study type
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
the oral administration of tadarafili
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1) I-PSS of 8 or higher
2) IPSS-QOL of 3 or higher
3) Prostate volume of 25 ml or higher
4) Qmax<15 ml/s with voided volume of 100 ml or more
Key exclusion criteria
Patients were excluded if they received oral treatment with alpha1-blockers, anticholinergic agents, antidepressants, 5ARI, anti-anxiety agents, or sex hormonal agents; had neurogenic bladder dysfunction, bladder calculi, or active urinary tract infection; had severe cardiac disease, renal dysfunction (serum-creatinine >2 mg/dL), hepatic dysfunction (aspartate aminotransferase and alanine aminotransferase more than twice the normal value).
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Matsukawa |
Organization
Nagoya University Graduate School of Medicine
Division name
department of Urology
Zip code
Address
65 tsurumai, Showa-ku, Nagoya, JAPAN
TEL
+81-52-744-2985
yoshi44@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Matsukawa |
Organization
Nagoya University Graduate School of Medicine
Division name
department of Urology
Zip code
Address
65 tsurumai, Showa-ku, Nagoya, JAPAN
TEL
+81-52-744-2985
Homepage URL
yoshi44@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, Japan
Institute
Department
Personal name
Funding Source
Organization
Nihon shinyaku pharmaceutical company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
none
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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 16 | Day |
Last modified on
| 2017 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020444
