UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015311
Receipt number R000017810
Scientific Title Efficacy of Alpha-Blocker Add-on Therapy to Tadarafil Treated Men with Lower Urinary Tract Sympton
Date of disclosure of the study information 2014/10/01
Last modified on 2019/04/05 21:29:57

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Basic information

Public title

Efficacy of Alpha-Blocker Add-on Therapy to Tadarafil Treated Men with Lower Urinary Tract Sympton

Acronym

Efficay of Alpha-Blocker Add-on Therapy to Tadarafil

Scientific Title

Efficacy of Alpha-Blocker Add-on Therapy to Tadarafil Treated Men with Lower Urinary Tract Sympton

Scientific Title:Acronym

Efficay of Alpha-Blocker Add-on Therapy to Tadarafil

Region

Japan


Condition

Condition

benign prostatic hypertrophy

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the efficacy of alpha-blocker plus tadarafil in men with lower urinary tract sympton after tadarafil monotherapy.

Basic objectives2

Others

Basic objectives -Others

Efficay and safety of alpha1A-specific blocker vs alpha1D-specific blocker is also evaluated.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

OABSS, IPSS and urodynamic parameter such as Qmax and residual volue of urine.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The patients were randomly divided into two groups: alpha1A blocker add-on group or alpha1D blocker add-on group.Patients in each group were administered drugs for 6 weeks. Following 2-week drug withdrawal period, the drug was changed and administered for another 6 weeks.

Interventions/Control_2

The patients were randomly divided into two groups: the silodosin add-on group or naftpidil add-on group.Patients in each group were administered drugs for 6 weeks. Following 2-week drug withdrawal period, the drug was changed and administered for another 6 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


Not applicable

Gender

Male

Key inclusion criteria

1. Prostate volume > 20cc
2. LUTS sympton (IPPS>8 and Qmax 5-15ml/sec) after taking tadarafil for 3 or more months.

Key exclusion criteria

1. Prostate cancer
2. Episode of urinary retention within 6 months
3. Residual urine volume >150ml
4. Urinary tract infection, neurogenic bladder

Target sample size

58


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ryuichi Mizuno

Organization

Keio University School of Medicine

Division name

Department of Urology

Zip code


Address

35 Shinanomachi, Shinjyuku, Tokyo

TEL

03-3353-1211

Email

mizunor@z7.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiaki Shinojima

Organization

Keio University School of Medicine

Division name

Department of Urology

Zip code


Address

35 Shinanomachi, Shinjyuku, Tokyo

TEL

03-3353-1211

Homepage URL


Email

t-shinoj@cd5.so-net.ne.jp


Sponsor or person

Institute

Department of Urology, Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Urology, Keio University School of Medicine

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

2014 Year 10 Month 01 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

2014 Year 10 Month 01 Day

Date of IRB

2014 Year 07 Month 25 Day

Anticipated trial start date

2014 Year 10 Month 01 Day

Last follow-up date

2019 Year 04 Month 05 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 10 Month 01 Day

Last modified on

2019 Year 04 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017810


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name