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

NCT ID: NCT01228370

Last Updated: 2012-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-01-31

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 neurogenic bladder.

α1-blockers seem to have a potential to reduce bladder outlet resistance during voiding in patients with neurogenic bladder.

Based on these turnouts, we designed this clinical study to evaluate the clinical effect and safety of silodosin on voiding dysfunction associated with neurogenic bladder.

Conditions

Neurogenic Bladder; Voiding Dysfunction

Keywords

sildosin; neurogenic bladder; voiding dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Silodosin

Silodosin 8mg once a day for 12 weeks

Group Type: EXPERIMENTAL

silodosin

Intervention Type: DRUG

silodosin 8mg once a day for 12 weeks

Interventions

silodosin

silodosin 8mg once a day for 12 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

JW Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Duk-Yoon Kim

Role: PRINCIPAL_INVESTIGATOR

Daegu Catholic University Medical Center

Chul-Hee Park

Role: PRINCIPAL_INVESTIGATOR

Keimyung Univ. Dongsan Medical Center

Hee-Chang Jung

Role: PRINCIPAL_INVESTIGATOR

Yeungnam Univ. Medical Center

Kyung-Hyun Moon

Role: PRINCIPAL_INVESTIGATOR

Ulsan Univ. Hospital

Tae-Hee Oh

Role: PRINCIPAL_INVESTIGATOR

Samsung Changwon Hospital

Jae-Soo Kim

Role: PRINCIPAL_INVESTIGATOR

Daegu Fatima Hospital

Locations

Daegu Catholic Univ. Medical Center

Daegu, Daegu City, South Korea

Daegu Fatima Hospital

Daegu, Daegu City, South Korea

Keimyung Univ. Dongsan Medical Center

Daegu, Daegu City, South Korea

Yeungnam Univ. Medical Center

Daegu, Daegu City, South Korea

Samsung Changwon Hospital

Changwon, Gyeongsangnam-do, South Korea

Ulsan Univ. Hospital

Ulsan, Ulsan City, South Korea

Countries

South Korea

Other Identifiers

CWP-SDS-402

Identifier Type: -

Identifier Source: org_study_id