UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study about the effect of silodosin on female voiding dysfunction
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Tomoyuki Uchiyama
Organization	Dokkyo Medical University
Division name	Neurourology and Continence Center
Address	880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
TEL	0282-86-1111
Email	t-uchi@dokkyomed.ac.jp

Public contact
Name of contact person	Tomoyuki Uchiyama
Organization	Dokkyo Medical University
Division name	Neurourology and Continence Center
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2008 Year 11 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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