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

NCT01228370 | Completed Phase 4

• 1 other identifier: CWP-SDS-402
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 6

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.

Conditions

Neurogenic Bladder; Voiding Dysfunction

Keywords

sildosin; neurogenic bladder; voiding dysfunction

Outcome Measures

Primary Outcomes (1)

• I-PSS score change after treatment

  12 weeks

Secondary Outcomes (3)

• 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

Study Arms (1)

Silodosin

EXPERIMENTAL

Silodosin 8mg once a day for 12 weeks

Drug: silodosin

Interventions

silodosin DRUG

silodosin 8mg once a day for 12 weeks

Silodosin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• JW Pharmaceutical: lead

Study Sites (6)

Daegu Catholic Univ. Medical Center

Daegu, Daegu City, South Korea

Location

Daegu Fatima Hospital

Daegu, Daegu City, South Korea

Location

Keimyung Univ. Dongsan Medical Center

Daegu, Daegu City, South Korea

Location

Yeungnam Univ. Medical Center

Daegu, Daegu City, South Korea

Location

Samsung Changwon Hospital

Changwon, Gyeongsangnam-do, South Korea

Location

Ulsan Univ. Hospital

Ulsan, Ulsan City, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Interventions

silodosin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2010
• First Posted: October 26, 2010
• Study Start: April 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: October 5, 2012

Record last verified: 2010-10

Locations

KR (6)