Clinical trial NCT01228370: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neurogenic Bladder
Voiding Dysfunction
Keywords: sildosin
neurogenic bladder
voiding dysfunction
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-10-26
Enrollment: 95
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: I-PSS score change after treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Qmax after treatment
timeFrame: 12 weeks
measure: Change in Postvoid Residual urine Volume(PRV) after treatment
timeFrame: 12 weeks
measure: Change in I-PSS Quality of Life after treatment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic Univ. Medical Center
state: Daegu City
city: Daegu
country: Korea, Republic of
facility: Daegu Fatima Hospital
state: Daegu City
city: Daegu
country: Korea, Republic of
facility: Keimyung Univ. Dongsan Medical Center
state: Daegu City
city: Daegu
country: Korea, Republic of
facility: Yeungnam Univ. Medical Center
state: Daegu City
city: Changwon
country: Korea, Republic of
facility: Samsung Changwon Hospital
state: Gyeongsangnam-do
city: Ulsan
country: Korea, Republic of
facility: Ulsan Univ. Hospital
state: Ulsan City
Study officials:
affiliation: Daegu Catholic University Medical Center
name: Duk-Yoon Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Keimyung Univ. Dongsan Medical Center
name: Chul-Hee Park
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeungnam Univ. Medical Center
name: Hee-Chang Jung
role: PRINCIPAL_INVESTIGATOR
affiliation: Ulsan Univ. Hospital
name: Kyung-Hyun Moon
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Changwon Hospital
name: Tae-Hee Oh
role: PRINCIPAL_INVESTIGATOR
affiliation: Daegu Fatima Hospital
name: Jae-Soo Kim
role: PRINCIPAL_INVESTIGATOR
References: