Benign Prostatic Hyperplasia
Conditions
Keywords
strong, silodosin, benign prostatic hyperplasia, BPH, lower urinary tract symptoms associated with severe BPH
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).
Interventions
DRUGSilodosin
Silodosin will be administered during 12 weeks, 8 mg (4 mg x 2 cap) QD with morning meal.
Sponsors
Chonnam National University Hospital
Kangdong Sacred Heart Hospital
Yeungnam University Hospital
Pusan National University Hospital
Seoul National University Hospital
Samsung Medical Center
Seoul St. Mary's Hospital
Korea University Guro Hospital
Chonbuk National University Hospital
Asan Medical Center
JW Pharmaceutical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total International prostate symptom score(IPSS) score before and after treatment | For 12 weeks | Assess the improvement of lower urinary tract symptoms with change in total IPSS score before and after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life(QoL) score before and after treatment | For 12 weeks | Assess the improvement of lower urinary tract symptoms with change in QoL score before and after treatment. |
| Maximal urinary flow rate(Qmax) before and after treatment | For 12 weeks | Assess the improvement of lower urinary tract symptoms with change in Qmax before and after treatment. |
| Voiding score of IPSS before and after treatment | For 12 weeks | Assess the improvement of lower urinary tract symptoms with change in voiding scores before and after treatment. |
| Storage scores of IPSS before and after treatment | For 12 weeks | Assess the improvement of lower urinary tract symptoms with change in storage scores before and after treatment. |
| Post void residual urine volume(PVR) before and after treatment | For 12 weeks | Assess the improvement of lower urinary tract symptoms with change in post void residual urine volume(PRV) before and after treatment. |
Countries
South Korea
Outcome results
None listed