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

A 12-week, Open-label, Multi-center Study to Evaluate the Clinical Efficacy and Safety of Silodosin on Voiding Dysfunction Associated With Neurogenic Bladder

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.

Study Overview

• Status: Completed
• Conditions: Neurogenic Bladder; Voiding Dysfunction
• Intervention / Treatment: Drug: silodosin

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu City
    • Daegu, Daegu City, Korea, Republic of
      • Daegu Catholic Univ. Medical Center
    • Daegu, Daegu City, Korea, Republic of
      • Daegu fatima hospital
    • Daegu, Daegu City, Korea, Republic of
      • Keimyung Univ. Dongsan Medical Center
    • Daegu, Daegu City, Korea, Republic of
      • Yeungnam Univ. Medical Center
  • Gyeongsangnam-do
    • Changwon, Gyeongsangnam-do, Korea, Republic of
      • Samsung Changwon Hospital
  • Ulsan City
    • Ulsan, Ulsan City, Korea, Republic of
      • Ulsan Univ. Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Silodosin; Silodosin 8mg once a day for 12 weeks	Drug: silodosin; silodosin 8mg once a day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
I-PSS score change after treatment	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: JW Pharmaceutical
• Investigators: Principal Investigator: Duk-Yoon Kim, Daegu Catholic University Medical Center; Principal Investigator: Chul-Hee Park, Keimyung Univ. Dongsan Medical Center; Principal Investigator: Hee-Chang Jung, Yeungnam Univ. Medical Center; Principal Investigator: Kyung-Hyun Moon, Ulsan Univ. Hospital; Principal Investigator: Tae-Hee Oh, Samsung Changwon Hospital; Principal Investigator: Jae-Soo Kim, Daegu fatima hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: October 25, 2010
• First Submitted That Met QC Criteria: October 25, 2010
• First Posted (Estimate): October 26, 2010

Study Record Updates

• Last Update Posted (Estimate): October 5, 2012
• Last Update Submitted That Met QC Criteria: October 3, 2012
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: neurogenic bladder; voiding dysfunction; sildosin
• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Urinary Bladder, Neurogenic; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Silodosin
• Other Study ID Numbers: CWP-SDS-402