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Recruitment status Terminated
Unique ID issued by UMIN UMIN000016034
Receipt No. R000018624
Scientific Title Effect of tadalafil on bladder blood flow in patients with lower urinary tract symptoms secondary to benign prostate hyperplasia
Date of disclosure of the study information 2015/12/22
Last modified on 2020/03/17

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Basic information
Public title Effect of tadalafil on bladder blood flow in patients with lower urinary tract symptoms secondary to benign prostate hyperplasia
Acronym Effect of tadalafil on bladder blood flow
Scientific Title Effect of tadalafil on bladder blood flow in patients with lower urinary tract symptoms secondary to benign prostate hyperplasia
Scientific Title:Acronym Effect of tadalafil on bladder blood flow
Region
Japan

Condition
Condition benign prostate hyperplasia
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the bladder blood flow in patients with benign prostate hyperplasia with control, and To assess the change in the bladder blood flow after treatment with tadalafil in patients with benign prostate hyperplasia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Difference in resistance index of the artery flowing into the bladder between the patients with benign prostate hyperplasia and control
2. Change in resistance index of the artery flowing into the bladder after treatment with tadalafil in patients with benign prostate hyperplasia
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Measurement of blood flow to the urinary bladder (healthy young man (20's and 30's) , patients without benign prostate hyperplasia (45 years or older), before and after 12 weeks of tadalafil therapy in patients with lower urinary tract symptoms secondary to benign prostate hyperplasia (45 years or older))
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
45 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1. male patients aged 45 or older
2. patients with lower urinary tract symptoms (IPSS: 8 points or more)
3. patients with prostate volume 20mL or more
4. patients with informed consent
Key exclusion criteria 1. patients with overactive bladder symptoms (OABSS: Q3 2points or more and total score 3 points or more)
2. patients who developed urinary retention in the past 12 months
3. patients strongly suspected of prostate cancer
4. patients with indwelling urethral catheter or intermittent self-catheterization
5. patients with acute urinary tract infection
6. patients with mechanical abnormality of lower urinary tract (eg. urethral stricture, bladder tumor and bladder stone)
7. patients without desire to void
8. patients with uncontrolled hypertension
9. patients with severe heart disease, renal dysfunction or liver dysfunction
10. patients tadalafil is contraindicated
11. patients who have been determined to be unsuitable as a subject by a physician
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiro Tambo
Organization Kyorin University School of Medicine
Division name Department of Urology
Zip code
Address 6-20-2, Shinkawa, Mitaka, Tokyo
TEL 0422-47-5511
Email tanbodes@ks.kyorin-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuhiro Tambo
Organization Kyorin University School of Medicine
Division name Department of Urology
Zip code
Address 6-20-2, Shinkawa, Mitaka, Tokyo
TEL 0422-47-5511
Homepage URL
Email tanbodes@ks.kyorin-u.ac.jp

Sponsor
Institute Department of Urology, Kyorin University School of Medicine
Institute
Department

Funding Source
Organization Department of Urology, Kyorin University School of Medicine
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

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 22 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
2014 Year 09 Month 08 Day
Date of IRB
2018 Year 04 Month 01 Day
Anticipated trial start date
2014 Year 09 Month 19 Day
Last follow-up date
2017 Year 09 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 12 Month 22 Day
Last modified on
2020 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018624

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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