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

Sponsor

JW Pharmaceutical (Industry)

Overall Status

Completed

CT.gov ID

NCT01228370

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

15.8

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neurogenic Bladder Voiding Dysfunction	Drug: silodosin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

95 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Silodosin

Silodosin 8mg once a day for 12 weeks

Drug: silodosin

silodosin 8mg once a day for 12 weeks

Outcome Measures

Primary Outcome Measures

I-PSS score change after treatment [12 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country
1	Daegu Catholic Univ. Medical Center	Daegu	Daegu City	Korea, Republic of
2	Daegu Fatima Hospital	Daegu	Daegu City	Korea, Republic of
3	Keimyung Univ. Dongsan Medical Center	Daegu	Daegu City	Korea, Republic of
4	Yeungnam Univ. Medical Center	Daegu	Daegu City	Korea, Republic of
5	Samsung Changwon Hospital	Changwon	Gyeongsangnam-do	Korea, Republic of
6	Ulsan Univ. Hospital	Ulsan	Ulsan City	Korea, Republic of