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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019286
Receipt No. R000022300
Scientific Title Efficacy of Silodosin on Storage and voiding functions in Patients with Benign Prostatic Hyperplasia: A Prospective Study based on Pressure Flow Study
Date of disclosure of the study information 2015/10/09
Last modified on 2015/10/08

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Basic information
Public title Efficacy of Silodosin on Storage and voiding functions in Patients with Benign Prostatic Hyperplasia: A Prospective Study based on Pressure Flow Study
Acronym Efficacy of Silodosin on Storage and voiding functions
Scientific Title Efficacy of Silodosin on Storage and voiding functions in Patients with Benign Prostatic Hyperplasia: A Prospective Study based on Pressure Flow Study
Scientific Title:Acronym Efficacy of Silodosin on Storage and voiding functions
Region
Japan

Condition
Condition Benign Prostatic Hyperplasia
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of the new sympathetic alpha1A-adrenoceptor antagonist silodosin on storage and voiding functions by pressure-flow study
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes The chnage of urodymamic parameters on storage and voiding functions before and after administration of silodosin
Key secondary outcomes The chnage of subjective parameters (IPSS, OABSS) before and after administration of silodosin

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 silodosin (8 mg/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

Not applicable
Gender Male
Key inclusion criteria 1) IPSS total score>8 points; 2) IPSS-QOL score>3 points; 3) prostate volume >20 mL as measured by transperitoneal or transrectal ultrasonography; 4) Qmax for urination of >100 mL <15 mL/second on uroflowmetry; 5) PVR <100 mL; and 6) patient age >50 years.
Key exclusion criteria (1) undergoing oral treatment with alpha-antagonists, anticholinergic agents, antidepressants, antianxiety agents, or anti-androgens; (2) suspected of having prostate cancer; (3) with neurogenic bladder dysfunction, bladder calculus, or active urinary tract infection; (4) with serious cardiac complications; (5) with renal complications (serum-creatinine >2 mg/dL); and (6) with hepatic dysfunction (aspartate aminotransferase (AST)/alanine aminotransferase (ALT) at least twofold higher than reference values).
Target sample size 100

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 Urology
Zip code
Address 65 Tsurumai, Showa-ku, Nagoya
TEL +81-52-744-2985
Email 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 Urology
Zip code
Address 65 Tsurumai, Showa-ku, Nagoya
TEL +81-52-744-2985
Homepage URL
Email yoshi44@med.nagoya-u.ac.jp

Sponsor
Institute Department of Urology
Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Urology
Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 名古屋大学医学部附属病院泌尿器科

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 09 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Silodosin improved lower urinary tract symptoms by improving bladder storage function and relieving bladder outlet obstruction. 
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 Completed
Date of protocol fixation
2007 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2007 Year 02 Month 01 Day
Last follow-up date
2013 Year 06 Month 30 Day
Date of closure to data entry
2013 Year 09 Month 30 Day
Date trial data considered complete
2013 Year 11 Month 30 Day
Date analysis concluded
2013 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 10 Month 08 Day
Last modified on
2015 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022300

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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