UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized comparative clinical study on alpha 1 receptor blockers silodosin and urapidil for female lower urinary tract symptoms
Title of the study (Brief title)	Randomized comparative clinical study on silodosin and urapidil for female lower urinary tract symptoms
Region	Japan

Condition
Condition	Lower urinary tract symptom
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the efficacy and safety of using silodosin for female lower urinary tract symptoms, using urapidil as a control drug.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	IPSS total score (at the initiation of administration, Week 4, Week 8, and Week 12)
Key secondary outcomes	I-PSS (QOL score), I-PSS (urinary storage symptom score), I-PSS (voiding symptom score), total OABSS score, residual urine measurement, urine flow measurement, blood pressure level, midway discontinuation rate, adverse drug reaction (at the initiation of administration, Week 4, Week 8, and Week 12) Pressure flow study, urination diary (at the initiation of administration and Week 12)

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	8 mg silodosin daily
Interventions/Control_2	60 mg urapidil daily
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Females aged 20 or older Patient with total I-PSS score of 8 or higher and residual urine of 50 mL or more Patient who can be examined at an outpatient clinic and from whom a written consent can be obtained on participation in the full scale study Reasons for setting the conditions: I-PSS 8 or higher indicates moderate to severe levels of BPH, and this index can be used to assess urinary storage, voiding, and postmicturition symptoms comprehensively. Because the subjects of this study are patients whose major complaints are voiding symptoms, the condition of residual urine being 50mL and over was added as an objective finding.
Key exclusion criteria	Patient with serious comorbid heart disease (such as ischemic heart disease, serious arrythmia, myocardial disease, and myocarditis) Patient with serious comorbid liver disease or total bilirubin level 3 mg/dL and over or AST(GOT) or ALT(GPT) 2.5 times and over the upper limit of the reference range Patient with serious comorbid kidney disease (such as nephrotic syndrome, acute kidney disease, acute nephritis, and chronic renal failure) or serum creatinine level are 1.5mg/dL and over Patient with serious hypotension Woman who is pregnant, nursing, wishes to become pregnant during the study period, or cannot follow physician's instructions regarding contraception Patient to whom urapidil was administered within 2 weeks of the initiation of the study Patient to whom another kind of alpha receptor blocker has been administered Patient for whom change or initiation of drug administration or change in dosage affecting urinary function was made within one month before initiation of the study Patient who have undergone radiotherapy for the pelvis Patient with active urinary tract infection Patient whose symptoms are considered to aggravate rapidly (such as urinary retention) due to cessation of urapidil Others judged to be unsuited as subjects according to the Principal Investigator
Target sample size	100

Research contact person
Name of lead principal investigator	Hirotsugu UEMURA
Organization	Kinki University Faculty of Medicine
Division name	Department of Urology
Address	377-2, Ohno-Higashi, Osaka-Sayama Osaka 589-8511, JAPAN
TEL	072-366-0221
Email	huemura@med.kindai.ac.jp

Public contact
Name of contact person	Nobutaka SHIMIZU
Organization	Kinki University Faculty of Medicine
Division name	Department of Urology
Address	377-2, Ohno-Higashi, Osaka-Sayama Osaka 589-8511, JAPAN
TEL	072-366-0221
Homepage URL
Email	shimizun@med.kindai.ac.jp

Sponsor
Institute	Kinki University Faculty of Medicine
Institute
Department

Funding Source
Organization	Kinki University Faculty of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2013 Year 09 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 09 Day
Anticipated trial start date	2013 Year 10 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	Partially published
URL releasing results	http://www.ics.org/abstracts/abstractssearch.aspx
Results
Other related information

Management information
Registered date	2013 Year 09 Month 13 Day
Last modified on	2018 Year 03 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013742