UMIN-CTR Clinical Trial

Public title

Randomized comparative clinical study on alpha 1 receptor blockers silodosin and urapidil for female lower urinary tract symptoms

Acronym

Randomized comparative clinical study on silodosin and urapidil for female lower urinary tract symptoms

Scientific Title

Randomized comparative clinical study on alpha 1 receptor blockers silodosin and urapidil for female lower urinary tract symptoms

Scientific Title:Acronym

Randomized comparative clinical study on silodosin and urapidil for female lower urinary tract symptoms

Region

Japan

Condition

Lower urinary tract symptom

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Hirotsugu UEMURA

Organization

Kinki University Faculty of Medicine

Division name

Department of Urology

Zip code

Address

377-2, Ohno-Higashi, Osaka-Sayama Osaka 589-8511, JAPAN

TEL

072-366-0221

Email

huemura@med.kindai.ac.jp

Name of contact person

1st name
Middle name
Last name	Nobutaka SHIMIZU

Organization

Kinki University Faculty of Medicine

Division name

Department of Urology

Zip code

Address

377-2, Ohno-Higashi, Osaka-Sayama Osaka 589-8511, JAPAN

TEL

072-366-0221

Homepage URL

Email

shimizun@med.kindai.ac.jp

Institute

Kinki University Faculty of Medicine

Institute

Department

Personal name

Organization

Kinki University Faculty of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

09

Month

13

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

http://www.ics.org/abstracts/abstractssearch.aspx

Number of participants that the trial has enrolled

Results

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

08

Month

09

Day

Date of IRB

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

Other related information

Registered date

2013

Year

09

Month

13

Day

Last modified on

2018

Year

03

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013742