UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001423
Receipt number R000001697
Scientific Title Randomized clinical study of silodosin vs propiverine for men aged 50 or older with overactivebladder and 20 to 30ml of prostate volume
Date of disclosure of the study information 2008/10/14
Last modified on 2010/11/09 11:58:42

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Randomized clinical study of silodosin vs propiverine for men aged 50 or older with overactivebladder and 20 to 30ml of prostate volume

Acronym

RCT of silodosin vs propiverine for men aged 50 or older

Scientific Title

Randomized clinical study of silodosin vs propiverine for men aged 50 or older with overactivebladder and 20 to 30ml of prostate volume

Scientific Title:Acronym

RCT of silodosin vs propiverine for men aged 50 or older

Region

Japan


Condition

Condition

Overactive bladder

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate effect and safety of silodosin and propiverine

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Proportion of patients who need treatment change or discontinuation within 8 weeks

Key secondary outcomes

OABSS, I-PSS total score, QoL index, voiding/storage subscore, maximal flow rate, postvoid residual urine volume (PVR), the ratio of patients with increasing PVR and adverse effect


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 considered as a block.

Blocking

YES

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Silodosin (4mg) 1 Capsule or Silodosin (2mg) 2 Capsules 2x1 after breakfast and dinner daily, orally

Interventions/Control_2

Propiverine (10mg) 1x1 after breakfast daily, orally

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) Men are aged 50 or older.
2) Prostate volume is 20ml or greater and less than 30ml by ultrasonography.
3) Overactive bladder is indicated by OABSS: urgency score 2 or greater and total score 5 or greater
4) Postvoid residual urine is 50ml or less.

Key exclusion criteria

1) Primary angle-closure glaucoma
2) Obstructive intestinal disease, paralytic ileus, gastrointerstinal atony, myastania gravis, severe heart disease
3) Cognitive disturbance
4) Active urinary tract infection
5) Past history of bladder and/or prostate surgery
6) Past history of bladder and/or prostate cancer
7) Treatment for benign prostate hyperplasia and/or overactive bladder within 3 months
8) Apparent neurological disease
9) judged as being unsuitable for the trial by the researcher

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoko Ishida

Organization

National Center for Geriatrics & Gerontology

Division name

Division of Urology

Zip code


Address

36-3, Gengo Morioka-cho Obu Aichi, Japan

TEL

0562-46-2311

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kikuo Okamura

Organization

National Center for Geriatrics & Gerontology

Division name

Division of Urology, Department of Surgery & Intensive Care

Zip code


Address

36-3, Gengo Morioka-cho Obu Aichi, Japan

TEL

0562-46-2311

Homepage URL


Email

kokamura@ncgg.go.jp


Sponsor or person

Institute

National Center for Geriatrics & Gerontology

Institute

Department

Personal name



Funding Source

Organization

National Center for Geriatrics & Gerontology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2008 Year 10 Month 14 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


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



Progress

Recruitment status

Terminated

Date of protocol fixation

2008 Year 04 Month 23 Day

Date of IRB


Anticipated trial start date

2008 Year 10 Month 01 Day

Last follow-up date

2011 Year 03 Month 01 Day

Date of closure to data entry

2011 Year 06 Month 01 Day

Date trial data considered complete

2011 Year 09 Month 01 Day

Date analysis concluded

2011 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 10 Month 09 Day

Last modified on

2010 Year 11 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001697


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name