UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020658 |
|---|---|
| Receipt number | R000023845 |
| Scientific Title | Study on the effect of tadalafil on bladder blood flow in patients with lower urinary tract symptoms due to benign prostatic hyperplasia |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2019/01/22 11:39:52 |
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Basic information
Public title
Study on the effect of tadalafil on bladder blood flow in patients with lower urinary tract symptoms due to benign prostatic hyperplasia
Acronym
Effect of tadalafil on bladder blood flow in benign prostatic hyperplasia
Scientific Title
Study on the effect of tadalafil on bladder blood flow in patients with lower urinary tract symptoms due to benign prostatic hyperplasia
Scientific Title:Acronym
Effect of tadalafil on bladder blood flow in benign prostatic hyperplasia
Region
| Japan |
Condition
Condition
Patients with lower urinary tract symptoms due to benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of tadalafil on bladder blood flow
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in resistive index of vesical artery on doppler ultrasound at 8 weeks after tadalafil administration
Key secondary outcomes
Base
Study type
Interventional
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
Administration of tadalafil 5mg once per day for 8 weeks
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
| 75 | years-old | > |
Gender
Male
Key inclusion criteria
I-PSS 13 or more, prostate volume 20ml or more, Qmax on uroflowmetry between 4 ml/sec and 15 ml/sec
Key exclusion criteria
postvoid residual urine 150 ml or more, uncontrolled diabetes mellitus, patients taking medication for lower urinary tract symptoms, patients who underwent surgery or radiation to the prostate
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidehiro Kakizaki |
Organization
Asahikawa Medical University
Division name
Department of Renal and Urologic Surgery
Zip code
Address
2-1-1-1 Midorigaoka-Higashi, Asahikawa, Japan
TEL
0166-68-2533
kaki@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidehiro Kakizaki |
Organization
Asahikawa Medical University
Division name
Department of Renal and Urologic Surgery
Zip code
Address
2-1-1-1 Midorigaoka-Higashi, Asahikawa, Japan
TEL
0166-68-2533
Homepage URL
kaki@asahikawa-med.ac.jp
Sponsor or person
Institute
Hidehiro Kakizaki
Institute
Department
Personal name
Funding Source
Organization
Asahikawa Medical University, Department of Renal and Urologic Surgery
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
旭川医科大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | 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
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
Terminated
Date of protocol fixation
| 2016 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 20 | Day |
Last modified on
| 2019 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023845
