Objective: To evaluate the efficacy and safety of Silodosin Capsules in the treatment of Benign Prostatic Hyperplasia (BPH) with Lower Urinary Tract Symptoms (LUTS) compared with Tamsulosin Hydrochloride Sustained Release Capsules. Study design: A multicenter, prospective, randomized, investigator-blind, active controlled clinical study. Interventions: Group A: Oral Tamsulosin Hydrochloride Capsules for 12 weeks. Group B: Oral l Silodosin Capsules for 12 weeks.
Sample size: 108
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
110
Silodosin is a α1A-adrenergic receptor antagonist which can relax the smooth muscle of bladder and prostate, relieves the dynamic obstruction of bladder outlet, and improves the lower urinary tract symptoms caused by BPH. The instruction of Silodosin Capsule (Qianweitai®) is 4mg/capsule,1 capsule/time, bid, after breakfast and dinner.
Tamsulosin is α1A-adrenergic receptor which has used in treatment of BPH for few years. The instruction of Tamsulosin Capsule is 1 tablet at a time, 1 time a day.
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
International Prostate Symptom Score(IPSS)
Changes of IPSS scores at the 12th week of treatment compared with baseline scores. The scores of the scale ranged from 0 to 35. The higher the score, the more severe the symptoms are.
Time frame: 12 week
International Prostate Symptom Score(IPSS) total score
Changes of IPSS scores at 1, 2, 4 and 8 weeks after treatment compared with baseline scores. The scores of the scale ranged from 0 to 35. The higher the score, the more severe the symptoms are.
Time frame: 1, 2, 4 and 8 weeks
IPSS Stimulus score
IPSS Stimulation Score at 12 weeks (Sum of Question 2, 4, 7) compared with baseline. The scores of the scale ranged from 0 to 15. The higher the score, the more severe the symptoms are.
Time frame: 12 weeks
IPSS obstruction score
Changes of IPSS obstruction score (sum of question 1, 3, 5, 6) at 12 weeks after treatment compared with baseline. The scores of the scale ranged from 0 to 20. The higher the score, the more severe the symptoms are.
Time frame: 12 weeks
IPSS total score severity
Distribution of IPSS total score severity grades at 12 weeks. The scores of the scale were divided into three grades: mild (0-7), moderate (8-19) and severe (20-35).
Time frame: 12 week
Quality of life (QoL) score
Changes in scores at 4, 8 and 12 weeks of treatment compared with baseline.The scores of the scale ranged from 0 to 6. The higher the score, the more severe the symptoms are.
Time frame: 4, 8 and 12 weeks
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Shenzhen, Guangdong, China
The Central Hospital Of WUHAN
Wuhan, Hubei, China
Wuhan No.1 Hospital
Wuhan, Hubei, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Wuxi No.2 People's Hospital
Wuxi, Jiangsu, China
Maximum urinary flow rate (Qmax)
The change of Qmax at 12 weeks of treatment compared with baseline.
Time frame: 12 weeks
Residual urine volume (PVR)
Changes of PVR at 12 weeks of treatment compared with baseline.
Time frame: 12 weeks
Patient response rate
Patient response rate is defined as the proportion of patients whose IPSS total score decreased by ≥ 25% compared with baseline value after treatment.
Time frame: 12 weeks