UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007917 |
|---|---|
| Receipt number | R000009312 |
| Scientific Title | Efficacy of silodosin in benign prostatic hyperplasia with overactive bladder. |
| Date of disclosure of the study information | 2012/05/09 |
| Last modified on | 2012/09/04 15:54:22 |
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Basic information
Public title
Efficacy of silodosin in benign prostatic hyperplasia with overactive bladder.
Acronym
Efficacy of silodosin in BPH/OAB
Scientific Title
Efficacy of silodosin in benign prostatic hyperplasia with overactive bladder.
Scientific Title:Acronym
Efficacy of silodosin in BPH/OAB
Region
| Japan |
Condition
Condition
Benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of silodosin between twice daily and once daily 4mg in BPH/OAB patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
International Prostate Symptom Score (IPSS)
Key secondary outcomes
Overactive bladder symptom score (OABSS)Uroflowmetry
Residual urine volume
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Silodosin 4mg once daily after supper
Interventions/Control_2
Silodosin 4mg twice daily after breakfast and supper
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) IPSS total score >=8 and QOL index >=2
2) OABSS urgency score >=2 and total score >=3
Key exclusion criteria
1) Patients who have a structural disease (e.g. prostatic cancer, bladder neck contracture, urethral stricture).
2) Patients with genitourinary surgery (e.g. TURP) or non-invasive treatment (e.g. balloon dilation, urethral stent, thermotherapy) within previous 6 months.
3) Patients with indwelling urethral cathether or clean-intermittent catheterization.
4) Patients with active urinary tract infections
5) Patients with neurogenic lower urinary tract disorders.
6) Patients having a history of allergic reaction caused by silodosin.
7) Patients who judged as being inadequate for this trial by the researcher.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Naito |
Organization
Kyushu University, Faculty of Medical Science
Division name
Department of Urology
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryosuke Takahashi |
Organization
Kyushu University, Faculty of Medical Science
Division name
Department of Urology
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
Homepage URL
Sponsor or person
Institute
Study group of voiding dysfunction in North part of Kyushu area
Institute
Department
Personal name
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
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
| 2012 | Year | 05 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2007 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | 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
| 2012 | Year | 05 | Month | 09 | Day |
Last modified on
| 2012 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009312
