UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020658
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kaki@asahikawa-med.ac.jp

Sponsor
Institute Hidehiro Kakizaki
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023845

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.