Exploratory study about the effect of silodosin on female voiding dysfunction

UMIN ID: UMIN000022024

Registered date:21/04/2016

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Voiding dysfunction
• Date of first enrollment: 2009/01/05
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Study drug group (Odd-numbered group): A 12-week administration of Silodosin 2 mg twice daily
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

Outcome(s)

• Primary Outcome: Score based on I-PSS

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 90years-old
• Gender: Female
• Exclude 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

Related Information

• Primary Sponsor: Dokkyo Medical University
• Source(s) of Monetary Support: self funding