UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparative study of safety and efficacy due to the dose change from 4 mg to 8 mg silodosin for benign prostatic hyperplasia with lower urinary tract symptoms
Title of the study (Brief title)	Comparative study of safety and efficacy due to the dose change from 4 mg to 8 mg silodosin for benign prostatic hyperplasia with lower urinary tract symptoms
Region	Japan

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

Objectives
Narrative objectives1	Comparative study of safety and efficacy due to the dose change from 4 mg to 8 mg silodosin for benign prostatic hyperplasia with lower urinary tract symptoms
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	IPSS Score, QOL Score, Blood pressure
Key secondary outcomes	maximum urinary flow rate (Qmax), residual urine volume

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Given the 4 mg once daily silodosin for 12 weeks in patients newly diagnosed with benign prostatic hyperplasia and, since then the 4 mg silodosin twice daily for 12 weeks
Interventions/Control_2	Given the 4 mg once daily silodosin for 12 weeks in patients taking another alpha-blocker with benign prostatic hyperplasia, since then the 4 mg silodosin twice daily for 12 weeks
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	80 years-old >
Gender	Male
Key inclusion criteria	1) Men aged over 50 and under 80 years old 2) International Prostate Symptom Score (IPSS) of>7 3) a prostate volume of >20ml 4) a maximum urinary flow rate (Qmax) of <15ml/s 5) The patients are obtained the informed consent 6) The patients undergone Wash out period 4 weeks or more (switching patients from another alpha-1 blocker)
Key exclusion criteria	1) patients are having the disease other than a benign prostatic hyperplasia (prostate cancer, bladder tumors, bladder stones, prostatitis, bladder neck sclerosis, patients, etc.) 2) Patients have received TUR-P, balloon dilation, urethral stent, hyperthermia, or radiation therapy to the pelvis, within 6 months of the start of the study 3) Self-catheterization 4) Patients with urinary tract infection 5) Patients with concomitant disease and other nervous system diseases, and it suspected to be neurogenic bladder 6) Patients with concomitant severe ischemic heart disease, cerebrovascular disease, liver dysfunction, renal dysfunction. 7) Patients with hypotension 8) Patients are having hypersensitivity to silodosin, naftopidil or taking vardenafil hydrochloride 9) Patients have treated with hormonal drug within 6 months 10) Patients treated with drugs other than tamsulosin is considered effective on urinary symptoms within a week 11) Patients was deemed by the physician as inappropriate to attend
Target sample size	200

Research contact person
Name of lead principal investigator	Masato Fujisawa
Organization	Kobe University Graduate School of Medicine
Division name	Division of Urology
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL	078-382-6155
Email	toshiro@med.kobe-u.ac.jp

Public contact
Name of contact person	Toshiro Shirakawa
Organization	Kobe University Graduate School of Medicine
Division name	Division of Urology
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL	078-382-6155
Homepage URL
Email	toshiro@med.kobe-u.ac.jp

Sponsor
Institute	Division of Urology, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Urology, Kobe University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hyogo PrefeCtural Awaji Hospital Miki City Hospital Kobe Ekisaikai Hospital, Shakaihoken Kobe Central Hospital
Name of secondary funｄer(s)

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	2012 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 01 Day
Anticipated trial start date	2012 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 07 Month 20 Day
Last modified on	2018 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009973