Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS

PHASE III, DOUBLE-BLIND, RANDOMIZED STUDY COMPARING THE EFFICACY AND SAFETY OF NAFTOPIDIL AND TAMSULOSIN TO TREATMENT THE SYMPTOMS OF LOWER URINARY TRACT IN PATIENTS WITH BENIGN PROSTATE HYPERPLASIA

The purpose of this study is to evaluate the effectiveness and safety of Naftopidil and Tamsulosin in the treatment of lower urinary tract symptoms through a comparative study of patients with benign prostatic hyperplasia.

Inclusion Criteria:

Men ≥ 50 years Signs and symptoms of BPH A total IPSS of ≥ 10 Prostate volume of ≥20 mL (estimated by ultrasonography) PVR > 150mL

Inclusion Criteria:

• Men ≥ 50 years
• Signs and symptoms of BPH
• IPSS of ≥ 10
• Prostate volume of ≥ 20 mL
• PVR > 150 mL

Exclusion Criteria:

• History of allergy to a AR antagonists
• Treatment with antiandrogen drugs
• Drugs with anticholinergic activity
• Significant history of orthostatic hypotension
• Concomitant neurological diseases
• Known or suspected neurogenic bladder dysfunction
• Carcinoma of the prostate or bladder
• Previous surgery for BPH or bladder neck obstruction
• History of recurrent UTI
• Concomitant active UTI