Efficacy and Safety of Silodosin on Voiding Dysfunction Associated With Neurogenic Bladder

Inclusion criteria

• Patient who is 20 years old or over
• Patient who is diagnosed with neurogenic bladder through urodynamic test, having urinary disorder symptoms
• In case, patient has been taking concomitant drugs allowed for the study, only if the doses have been stable within 8 weeks from the screening visit
• Patient who has a I-PSS score of 8 or over
• Patient who has a QoL score of 3 or over
• Patient who has a Qmax of below 15 mL/sec
• Patient who has a PSA<4.0 ng/mL or has PSA>4.0 ng/mL with no opinion of prostate cancer from biopsy
• Patient who is willing to take the investigational product in accordance with the protocol
• Patient who is able to fill out questionnaire and understand requirements of the study including informed consent
• Patient voluntarily decides to participate and signs the written consent form.

Exclusion criteria

• Patient who hs urinate at all on his/her own.
• Patient who has a history of bladder surgery
• Patient who has detrusor areflexia or acontractile bladder diagnosed by urodynamic test
• Patient who has a postvoid residual urine volume(PRV) of 300 mL or greater, or has a PRV of 50% or over of the maximum bladder capacity
• Patient who has a prostate volume of 30 mL or greater resulted from a severe benign prostatic hyperplasia(BPH) (only in case of male)
• Patient who has urethral stricture
• Patient who has symptomatic urinary tract infection(UTI) before screening visit
• Patient who has a gross hematuria(except idiopathic hematuria)
• Patient who conducts Clean Intermittent Catheterization(CIC)
• Patient who has been taking α-blocker other than silodosin or α-agonist within 8 weeks from screening visit
• Patient who has a Botulinum toxin injection for bladder problems within at least 1 year from screening visit
• Patient who has severe hapatic disorders(hepatic insufficiency, cirrhosis, jaundice, hepatoma)or has a total bilirubin of 2.5 mg/dL or higher or has AST/ALT 2.5 times higher than the normal upper limit
• Patient who has a renal impairment with a serum creatinine 2.0 mg/dL or higher
• Patient who has experienced severe arrhythmia, cardiac failure, myocardiac infarction, unstable angina, cerebral infarction within 6 months from screening visit
• Patient who has orthostatic hypotention before screening visit
• Patient who has a demanding chronic disease
• Patient who has an allergy to drugs
• Patient who is prohibited from taking silodosin
• Patient who has to take drugs prohibited from the study during the clinical study
• Patient who is pregnant or plans to be pregnant or is breastfeeding or is not practicing contraception using medically acceptable contracenption
• Patient who has experienced any other clinical study within 4 weeks from screening visit
• Patient who is excluded from medical dicisions made by the investigators