Efficacy and Safety of Combination Therapy Compared With Monotherapy in Patients With Benign Prostatic Hyperplasia
Men aged 45 years or older.
Participants diagnosed with benign prostatic hyperplasia (BPH).
Prostate volume of ≥30 mL as measured by transrectal ultrasonography (TRUS).
Participants considered capable of completing the questionnaires.
Participants with hypersensitivity to the investigational medicinal product, its components, or sulfonamides.
Malignancy of the pelvic organs (bladder, prostate, or rectum).
Prostate surgery or other invasive procedures (e.g., robotic simple prostatectomy, radiofrequency therapy, or minimally invasive treatment).
Urethrotomy or other surgery that may affect urinary flow, or pelvic surgery.
Parallel
Finasteride 5 mg Tablet, single dose
DrugFinasteride 5mg administered orally once daily
Tamsulosin 0.4Mg Capsule
DrugTamsulosin 0.4mg capsule administered orally once daily
Total IPSS
Change from baseline in total International Prostate Symptom Score (total IPSS) at Week 48 after treatment
Total IPSS
Change from baseline in total International Prostate Symptom Score (total IPSS) at Weeks 4, 12, 24, and 36 after treatment
IPSS Quality of Life
Change from baseline in the International Prostate Symptom Score (IPSS) quality of life (QoL) score at Weeks 4, 12, 24, 36, and 48 after treatment
IPSS Voiding Symptoms
Change from baseline in the IPSS voiding symptom domain score at Weeks 4, 12, 24, 36, and 48 after treatment
IPSS Storage Symptoms
Change from baseline in the IPSS storage symptom domain score at Weeks 4, 12, 24, 36, and 48 after treatment
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