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

• silodosin (Drug): silodosin 8mg once a day for 12 weeks

Primary outcomes

• I-PSS score change after treatment [12 weeks]

Secondary outcomes

• Change in Qmax after treatment [12 weeks]
• Change in Postvoid Residual urine Volume(PRV) after treatment [12 weeks]
• Change in I-PSS Quality of Life after treatment [12 weeks]

Sex: All, ages: 20 Years to any

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

• Duk-Yoon Kim, Principal investigator, Daegu Catholic University Medical Center
• Chul-Hee Park, Principal investigator, Keimyung Univ. Dongsan Medical Center
• Hee-Chang Jung, Principal investigator, Yeungnam Univ. Medical Center
• Kyung-Hyun Moon, Principal investigator, Ulsan Univ. Hospital
• Tae-Hee Oh, Principal investigator, Samsung Changwon Hospital
• Jae-Soo Kim, Principal investigator, Daegu Fatima Hospital