Lower urinary tract symptom
Conditions
Interventions
8 mg silodosin daily
60 mg urapidil daily
Sponsors
Kinki University Faculty of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Females aged 20 or older Patient with total I-PSS score of 8 or higher and residual urine of 50 mL or more Patient who can be examined at an outpatient clinic and from whom a written consent can be obtained on participation in the full scale study Reasons for setting the conditions: I-PSS 8 or higher indicates moderate to severe levels of BPH, and this index can be used to assess urinary storage, voiding, and postmicturition symptoms comprehensively. Because the subjects of this study are patients whose major complaints are voiding symptoms, the condition of residual urine being 50mL and over was added as an objective finding.
Exclusion criteria
Exclusion criteria: Patient with serious comorbid heart disease (such as ischemic heart disease, serious arrythmia, myocardial disease, and myocarditis) Patient with serious comorbid liver disease or total bilirubin level 3 mg/dL and over or AST(GOT) or ALT(GPT) 2.5 times and over the upper limit of the reference range Patient with serious comorbid kidney disease (such as nephrotic syndrome, acute kidney disease, acute nephritis, and chronic renal failure) or serum creatinine level are 1.5mg/dL and over Patient with serious hypotension Woman who is pregnant, nursing, wishes to become pregnant during the study period, or cannot follow physician's instructions regarding contraception Patient to whom urapidil was administered within 2 weeks of the initiation of the study Patient to whom another kind of alpha receptor blocker has been administered Patient for whom change or initiation of drug administration or change in dosage affecting urinary function was made within one month before initiation of the study Patient who have undergone radiotherapy for the pelvis Patient with active urinary tract infection Patient whose symptoms are considered to aggravate rapidly (such as urinary retention) due to cessation of urapidil Others judged to be unsuited as subjects according to the Principal Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IPSS total score (at the initiation of administration, Week 4, Week 8, and Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| I-PSS (QOL score), I-PSS (urinary storage symptom score), I-PSS (voiding symptom score), total OABSS score, residual urine measurement, urine flow measurement, blood pressure level, midway discontinuation rate, adverse drug reaction (at the initiation of administration, Week 4, Week 8, and Week 12) Pressure flow study, urination diary (at the initiation of administration and Week 12) | — |
Countries
Japan
Contacts
Public ContactNobutaka SHIMIZU
Kinki University Faculty of Medicine Department of Urology
Outcome results
None listed