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

Primary Purpose

Neurogenic Bladder, Voiding Dysfunction

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

silodosin

About this trial

This is an interventional treatment trial for Neurogenic Bladder focused on measuring sildosin, neurogenic bladder, voiding dysfunction

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Daegu Catholic Univ. Medical Center
Daegu Fatima Hospital
Keimyung Univ. Dongsan Medical Center
Yeungnam Univ. Medical Center
Samsung Changwon Hospital
Ulsan Univ. Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Silodosin

Arm Description

Silodosin 8mg once a day for 12 weeks

Outcomes

Primary Outcome Measures

I-PSS score change after treatment

Secondary Outcome Measures

Change in Qmax after treatment

Change in Postvoid Residual urine Volume(PRV) after treatment

Change in I-PSS Quality of Life after treatment

Full Information

NCT ID

NCT01228370

First Posted

October 25, 2010

Last Updated

October 3, 2012

Sponsor

JW Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT01228370

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

JW Pharmaceutical

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurogenic Bladder, Voiding Dysfunction

Keywords

sildosin, neurogenic bladder, voiding dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

95 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Silodosin

Arm Type

Experimental

Arm Description

Silodosin 8mg once a day for 12 weeks

Intervention Type

Drug

Intervention Name(s)

silodosin

Intervention Description

silodosin 8mg once a day for 12 weeks

Primary Outcome Measure Information:

Title

I-PSS score change after treatment

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change in Qmax after treatment

Time Frame

12 weeks

Title

Change in Postvoid Residual urine Volume(PRV) after treatment

Time Frame

12 weeks

Title

Change in I-PSS Quality of Life after treatment

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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

Overall Study Officials: