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

Neurogenic Bladder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01228370
• Other study ID #: CWP-SDS-402
• Status: Completed
• Phase: Phase 4
• First received: October 25, 2010
• Last updated: October 3, 2012
• Start date: April 2011
• Est. completion date: January 2012

Study information

• Verified date: October 2010
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 a-blocker other than silodosin or a-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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neurogenic Bladder
• Urinary Bladder, Neurogenic
• Voiding Dysfunction

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Changwon Hospital	Changwon	Gyeongsangnam-do
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	Daegu	Daegu City
Korea, Republic of	Ulsan Univ. Hospital	Ulsan	Ulsan City

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	I-PSS score change after treatment		12 weeks	No
Secondary	Change in Qmax after treatment		12 weeks	No
Secondary	Change in Postvoid Residual urine Volume(PRV) after treatment		12 weeks	No
Secondary	Change in I-PSS Quality of Life after treatment		12 weeks	No