Study of a α1A Adrenoceptor Selective Antagonist Silodosin to Treat Severe Benign Prostatic Hyperplasia(BPH)

Study Overview
=================
Brief Summary
-----------------
This clinical study is designed to evaluate the efficacy and safety of silodosin in a 12 week treatment of patients with severe urinary disorders associated with benign prostatic hyperplasia (BPH).

Official Title
-----------------
A 12-week, Open Label, Multi-center Study to Investigate the Efficacy and Safety of a α1A Adrenoceptor Selective Antagonist Silodosin on Urinary Disturbance Associated With Benign Prostatic Hyperplasia

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: Silodosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is at least 50 years old Has a urinary disturbance associated with severe BPH and has a total IPSS score 20 or higher Has a QoL score of 3 or higher Has a urine volume of 120mL or greater and a Qmax of below 15mL/sec Has a PRV of below 100mL Voluntarily decides to participate in this trial and sign with informed consent form Exclusion Criteria: Has been administered silodosin Has been administered an α1A-adrenoceptor blocker within one month Has been prescribed antiandrogens except 5α-reductase inhibitors within a year Has had phytotherapy within 3 months Has had prostatectomy Has had intrapelvic radiation therapy Has had transurethral microwave hyperthermia of transurethral needle ablation Is suspected to have implications that are likely to affect urine passing such as neurogenic bladder, bladder calculus or active urinary tract infection (UTI). Is conducting self-catherterization Has a renal impairment with a serum creatinine of 2.0mg/dL or greater Has severe hepatic disorders (hepatic insufficiency, cirrhosis, jaundice, hepatoma) or has a total bilirubin of 2.5mg/dl or higher or has AST/ALT 2.5 times higher than the normal (upper) level Has suffered from a severe arrhythmia, cardiac failure, cardiac infarction, unstable angina, cerebral infarction within 6 months Has experienced allergy to α1 receptor blockers Has orthostatic hypotension around the time of Screening Visit Has participated in other clinical trials within 8 weeks prior to Screening Visit Has a Prostate specific antigen(PSA) of higher 10ng/mL or has been diagnosed with tumor identified by a biopsy even though he has a PSA of lower 10ng/mL (Patient who has been administered 5α-reductase inhibitors for more than 3 months are presumed to have 2 times higher than their actual PSA levels) Has been taking unstable dosing of 5α-reductase inhibitors like finasteride or dutasteride for the past 3 months or is expected to change the dosage during the trial.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silodosin<br>Silodosin will be administered during 12 weeks, 8 mg (4 mg x 2 cap) QD with morning meal. | Drug: Silodosin<br>* Silodosin will be administered during 12 weeks, 8 mg (4 mg x 2 cap) QD with morning meal.<br>* Other names: Brand name in Korea : THRUPAS;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total International prostate symptom score(IPSS) score before and after treatment | Assess the improvement of lower urinary tract symptoms with change in total IPSS score before and after treatment. | For 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life(QoL) score before and after treatment | Assess the improvement of lower urinary tract symptoms with change in QoL score before and after treatment. | For 12 weeks | 
| Maximal urinary flow rate(Qmax) before and after treatment | Assess the improvement of lower urinary tract symptoms with change in Qmax before and after treatment. | For 12 weeks | 
| Voiding score of IPSS before and after treatment | Assess the improvement of lower urinary tract symptoms with change in voiding scores before and after treatment. | For 12 weeks | 
| Storage scores of IPSS before and after treatment | Assess the improvement of lower urinary tract symptoms with change in storage scores before and after treatment. | For 12 weeks | 
| Post void residual urine volume(PVR) before and after treatment | Assess the improvement of lower urinary tract symptoms with change in post void residual urine volume(PRV) before and after treatment. | For 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
strong, silodosin, benign prostatic hyperplasia, BPH, lower urinary tract symptoms associated with severe BPH