UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022024 |
|---|---|
| Receipt number | R000025380 |
| Scientific Title | Exploratory study about the effect of silodosin on female voiding dysfunction |
| Date of disclosure of the study information | 2016/04/21 |
| Last modified on | 2016/04/21 23:38:12 |
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Basic information
Public title
Exploratory study about the effect of silodosin on female voiding dysfunction
Acronym
Exploratory study about the effect of silodosin on female voiding dysfunction
Scientific Title
Exploratory study about the effect of silodosin on female voiding dysfunction
Scientific Title:Acronym
Exploratory study about the effect of silodosin on female voiding dysfunction
Region
| Japan |
Condition
Condition
Voiding dysfunction
Classification by specialty
| Neurology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is intended to evaluate the efficacy, safety, and quality of life of Silodosin 4 or 8 mg in a 3-month administration for treatment of voiding dysfunction in patients with neurogenic bladder.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Score based on I-PSS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Study drug group (Odd-numbered group):
A 12-week administration of Silodosin 2 mg twice daily
Interventions/Control_2
Study drug group(Even-numbered group):
A 8-week administration of Silodosin 4 mg twice daily after a 4-week administration of Silodosin 2 mg twice 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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Female
Key inclusion criteria
1)over 50ml residual urine volume
or
2)over 2 points I-PSS
and
3)patinets who can answer the questionnaire
4)out-patient
5)Patients who agree to contraception use
Key exclusion criteria
1)severe heart disease
2)severe liver diseae or over 3mg/dl total bilirubin or over 2.5 times AST(GOT)o ALT(GPT)
3)severe kidney disease or over 1.5mg/dl creatinine
4)severe hypotention
5)women who are pregnant, breast-feeding, or seeking to conceive or may conceive due to improper contraception method during the study period
6)Patients receiving surgical therapy, which may influence the lower urinary tract function
7)Patients receiving nonpharmacologic therapy within 4 weeks prior to the study commencement, which may influence the lower urinary tract function
8)Patients who received an investigational drug in other clinical study within 1 month prior to the study commencement (the period of which should be calculated based on the date on which the investigational drug was administered)
9)Patients who are otherwise ineligible to take part in the study as judged by Principal Investigator or other relevant person
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Uchiyama |
Organization
Dokkyo Medical University
Division name
Neurourology and Continence Center
Zip code
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
TEL
0282-86-1111
t-uchi@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Uchiyama |
Organization
Dokkyo Medical University
Division name
Neurourology and Continence Center
Zip code
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
TEL
0282-86-1111
Homepage URL
t-uchi@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
| 2016 | Year | 04 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2008 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 05 | 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
| 2016 | Year | 04 | Month | 21 | Day |
Last modified on
| 2016 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025380
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
