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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017261
Receipt No. R000020012
Scientific Title Effect of Tamsulosin for Benign Prostate Hyperplasia patient with persistent symptoms: switch from Silodosin.
Date of disclosure of the study information 2015/04/24
Last modified on 2015/11/25

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Basic information
Public title Effect of Tamsulosin for Benign Prostate Hyperplasia patient with persistent symptoms: switch from Silodosin.
Acronym Effect of Tamsulosin for Benign Prostate Hyperplasia patient with persistent symptoms: switch from Silodosin.
Scientific Title Effect of Tamsulosin for Benign Prostate Hyperplasia patient with persistent symptoms: switch from Silodosin.
Scientific Title:Acronym Effect of Tamsulosin for Benign Prostate Hyperplasia patient with persistent symptoms: switch from Silodosin.
Region
Japan

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

Objectives
Narrative objectives1 To examine efficacy and safety of switch from Silodosin to 0.2 mg Tamsulosin.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes International Prostate Symptom score
Key secondary outcomes

Base
Study type

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 To examine efficacy and safety of switch from Silodosin to 0.2 mg Tamsulosin. (12weeks)
Interventions/Control_2
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. male patients aged 50 or older
2. patients treated with Silodosin 8mg for over 8 weeks
3. question number 3 of QOL score: 3 points or more
4. patients with lower urinary tract symptoms (IPSS: 8 points or more, QOL score 3 points or more)
5. patients who want to change from Silodosin to Tamsulosin
6. patients with informed consent
Key exclusion criteria 1. patients treated with other alpha 1 blocker
2. patients Tamsulosin is contraindicated
3. patients treated with anti cholonergic agents
4. patients treated with anti androgen agents
5. patients treated with drug could change urination
6. patients with prostate cancer
7. patients with the history of TUR-P
8. patients with the history of hyperthermia for benign prostatic hyperplasia
9. patients with neurogenic bladder
10. patients with urethral stricture
11. patients with using self catheterization
12. patients with the history of radiation therapy
13. patients with active urinary infection
14. patients who have been determined to be unsuitable as a subject by a physician
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiko Mitsui
Organization Hokkaido University Graduate School of Medicine
Division name Department of Renal and Genitourinary surgery
Zip code
Address North 15, West 7, Kita-ku, Sapporo, 060-8638, Japan
TEL 011-706-5966
Email mitsui68@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiko Mitsui
Organization Hokkaido University Graduate School of Medicine
Division name Department of Renal and Genitourinary surgery
Zip code
Address North 15, West 7, Kita-ku, Sapporo, 060-8638, Japan
TEL 011-706-5966
Homepage URL
Email mitsui68@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

Funding Source
Organization none
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
2015 Year 04 Month 24 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 Completed
Date of protocol fixation
2010 Year 04 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 23 Day
Last modified on
2015 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020012

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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