Clinical Trial to Compare the Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for LUTS Due to BPH

Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy with Tamsulosin Monotherapy for Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia

Inclusion Criteria:

• Over 45 years
• Benign Prostate Hyperplasia diagnosed by 20 mL < TRUS
• Lower urinary tract symptom suggestive of benign prostate hyperplasia, who spontaneously agree to join and sign to the consent form

Exclusion Criteria:

• Subjects who have a history of the lower urinary tract cancer, including prostate cancer and bladder cancer within the past 3 years
• Subjects who have acute urinary retention within 12 weeks before screening
• Subjects who have clinically significant severe cardiovascular disease(unstable angina, myocardial infarction or arrhythmia) within 24 weeks before screening
• Subjects who have hypersensitivity to investigational product
• Subjects who were suspected or confirmed neurogenic bladder, bladder neck structure, bladder diverticulum
• Subjects who have myasthenia gravis, narrow angle glaucoma
• Subjects who have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• SBP > 180 mmHg or DBP > 100 mmHg
• HbA1c > 9.0 %
• Subjects who are judged by the investigators to be unsuitable to participate in the clinical trial.