UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of the long-term efficacy of silodosin and tamsulodin for the tratment of benign prostatic hyperplasia
Title of the study (Brief title)	Long-term effect of silodosin and tamsulodin
Region	Japan

Condition
Condition	benign prostatic hyperplasia
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacies of silodosin ad tamsulosin for the treatment of benign prostatic hyperplasia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase IV

Assessment
Primary outcomes	Changes in IPSS
Key secondary outcomes	Uroflowmetry, bladder diary

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Tamsulodsin
Interventions/Control_2	Silodosin
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	90 years-old >
Gender	Male
Key inclusion criteria	1) a total IPSS of 8 or more, 2) maximum flow rate of 15 ml per second or less as evaluated by uroflowmetry, 3) prostate volume of 15 ml or more as measured by prostatic ultrasonography.
Key exclusion criteria	1) with prostatic cancer, prostatitis and urethral stricture, 2) with severe cardiac or cerebrovascular disorders, hepatic disorders, renal dysfunction, 4) on medication with anti-cholinergics, other alpha-AR antagonists, Beta-AR agonists or antagonists, or anti-androgen drugs during 1 month prior to the study.
Target sample size	200

Research contact person
Name of lead principal investigator	Tomonori Yamanishi
Organization	Dokkyo Medical University
Division name	Continence center
Address	880 Kitakobayashi, Mibu, Tochigi,
TEL	0282-86-1111
Email	yamanish@dokkyomed.qc.jp

Public contact
Name of contact person	Tomonori Yamanishi
Organization	Dokkyo Medical University
Division name	Continence center
Address	880 Kitakobayashi, Mibu, Tochigi
TEL	0282-86-1111
Homepage URL
Email	yamanish@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University
Institute
Department

Funding Source
Organization	dokkyo Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
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	獨協医科大学泌尿器科

Other administrative information
Date of disclosure of the study information	2012 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 04 Month 01 Day
Anticipated trial start date	2006 Year 04 Month 01 Day
Last follow-up date	2013 Year 03 Month 31 Day
Date of closure to data entry	2013 Year 04 Month 01 Day
Date trial data considered complete	2013 Year 04 Month 01 Day
Date analysis concluded	2013 Year 04 Month 01 Day

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

Management information
Registered date	2012 Year 07 Month 26 Day
Last modified on	2018 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009154