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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022024
Receipt No. 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

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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
Email 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
Email t-uchi@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025380

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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