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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019289
Receipt No. R000022306
Scientific Title What are the factors contributing to failure in improvement of subjective symptoms following silodosin administration in patients with benign prostatic hyperplasia? Investigation using a pressure-flow study.
Date of disclosure of the study information 2015/10/09
Last modified on 2015/10/09

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Basic information
Public title What are the factors contributing to failure in improvement of subjective symptoms following silodosin administration in patients with benign prostatic hyperplasia? Investigation using a pressure-flow study.
Acronym Factors contributing to a failure in subjective improvement following alpha-blocker administration
Scientific Title What are the factors contributing to failure in improvement of subjective symptoms following silodosin administration in patients with benign prostatic hyperplasia? Investigation using a pressure-flow study.
Scientific Title:Acronym Factors contributing to a failure in subjective improvement following alpha-blocker administration
Region
Japan

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

Objectives
Narrative objectives1 To investigate the factors responsible for failure in improvement of subjective symptoms following silodosin treatment on the basis of findings of a pressure-flow study
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes To compare patient background and objective findings from PFS performed at baseline and post-treatment between good and poor responders in symptom improvement.
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 a silodosin capsule 4 mg twice daily (8 mg/day) for 4 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) an IPSS total score of 8 or greater; 2) an IPSS-quality of life (QOL) score of 3 or greater; 3) prostate volume measured by transabdominal or transrectal echography of 20 mL or greater; 4) maximum flow rate (Qmax) by uroflowmetry (UFM) of less than 15 mL/sec at a voiding volume of greater than 100 mL; 5) post-void residual urine volume (PVR) of less than 150 mL; and 6) age of 50 years or older.
Key exclusion criteria Patients currently receiving alpha-blockers, anticholinergic drugs, antidepressants, antianxiety drugs and/or sex hormones, those with suspected prostate cancer, neurovesical dysfunction, bladder stone or active urinary tract infection were excluded. Patients with any serious cardiac complication, renal complication (serum creatinine of 2 mg/dl or greater) or hepatic complication (AST and ALT that are at least double the reference values) were also excluded.
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 Department of 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 Department of 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

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
The findings suggest that insufficient improvement in storage function is a contributing factor to a failure in subjective improvement after silodosin treatment in patients with BPH.
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
2009 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2012 Year 12 Month 31 Day
Date of closure to data entry
2013 Year 01 Month 31 Day
Date trial data considered complete
2013 Year 03 Month 31 Day
Date analysis concluded
2013 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 10 Month 09 Day
Last modified on
2015 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022306

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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