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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01228370
First received: October 25, 2010
Last updated: October 3, 2012
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Neurogenic Bladder
Voiding Dysfunction
Drug: silodosin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 12-week, Open-label, Multi-center Study to Evaluate the Clinical Efficacy and Safety of Silodosin on Voiding Dysfunction Associated With Neurogenic Bladder

Resource links provided by NLM:


Further study details as provided by JW Pharmaceutical:

Primary Outcome Measures:
  • I-PSS score change after treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Qmax after treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Postvoid Residual urine Volume(PRV) after treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in I-PSS Quality of Life after treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: April 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Silodosin
Silodosin 8mg once a day for 12 weeks
Drug: silodosin
silodosin 8mg once a day for 12 weeks

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228370

Locations
Korea, Republic of
Daegu Catholic Univ. Medical Center
Daegu, Daegu City, Korea, Republic of
Keimyung Univ. Dongsan Medical Center
Daegu, Daegu City, Korea, Republic of
Yeungnam Univ. Medical Center
Daegu, Daegu City, Korea, Republic of
Daegu Fatima Hospital
Daegu, Daegu City, Korea, Republic of
Samsung Changwon Hospital
Changwon, Gyeongsangnam-do, Korea, Republic of
Ulsan Univ. Hospital
Ulsan, Ulsan City, Korea, Republic of
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT01228370     History of Changes
Other Study ID Numbers: CWP-SDS-402
Study First Received: October 25, 2010
Last Updated: October 3, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by JW Pharmaceutical:
sildosin
neurogenic bladder
voiding dysfunction

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014