UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019286 |
|---|---|
| Receipt number | 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 19:25:15 |
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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
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
yoshi44@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Urology
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022300
