Status:
COMPLETED
Efficacy and Safety of Silodosin on Voiding Dysfunction Associated With Neurogenic Bladder
Lead Sponsor:
JW Pharmaceutical
Conditions:
Neurogenic Bladder
Voiding Dysfunction
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
Because the bladder neck and proximal urethra contain abundant α1-adrenergic receptors, α-blockers or α1-blockers are well-known to reduce bladder neck obstruction in patients with or without neurogen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT01228370
Start Date
April 1 2011
End Date
January 1 2012
Last Update
October 5 2012
Active Locations (6)
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1
Daegu Catholic Univ. Medical Center
Daegu, Daegu City, South Korea
2
Daegu Fatima Hospital
Daegu, Daegu City, South Korea
3
Keimyung Univ. Dongsan Medical Center
Daegu, Daegu City, South Korea
4
Yeungnam Univ. Medical Center
Daegu, Daegu City, South Korea