UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019289
Receipt number 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 00:44:21

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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 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


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

Value
https://center6.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