The goal of this clinical trial is to learn if Qianweitai (QWT, silodosin capsule) works to treat BPH/LUTS in male adults. It will also learn the safety about QWT. The main questions it aims to answer are: 1. Whether QWT is non inferior to tamsulosin in the reduction of IPSS total score? 2. Dose QWT have other advantages in the improvement of LUTS? Participants will: 1. Orally take QWT twice daily or tamsulosin once daily for 12 weeks. 2. Visit the clinic at week 1、 2、4、8 and 12 for checkups and tests.
This trial is designed as two stages: screening period, treatment and follow-up period. Screening period (days -28 to 0): After signing the informed consent form, the subjects entered into the screening period, and made a 24-hour urination diary and screening examination. Treatment and Follow-up period: eligible patients were randomly assigned to 2 groups according to 1: 1 and received Tamsulosin or Silodosin or for 12 weeks. During the treatment period, the subjects' diaries were recorded according to the requirements of the scheme, and they were followed up at 1 week (7±2 days), 2 weeks (14±3), 4 weeks (28±5 days), 8 weeks (56±7 days) and 12 weeks (84±10 days). During the visit, relevant scale scores and laboratory examinations were performed, and the occurrence of adverse events during the follow-up was recorded to evaluate the safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
110
Silodosin is an α1A-adrenergic receptor antagonist which can relax the smooth muscle of bladder and prostate, relieve the dynamic obstruction of bladder outlet, and improve 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 an α1A-adrenergic receptor blocker 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.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Wuhan Center Hospital
Wuhan, Hubei, China
Wuhan No.1 Hospital
Wuhan, Hubei, China
The Second Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China
Beijing Tongren Hospital, Capital Medical University
Beijing, China
Ciivil Aviation General Hospital
Beijing, China
International Prostate Symptom Score(IPSS)
Changes of IPSS scores at the 12th week of treatment compared with baseline scores.
Time frame: week 12
International Prostate Symptom Score(IPSS) total score
Changes of IPSS scores at 1, 2, 4 and 8 weeks after treatment compared with baseline
Time frame: 1, 2, 4 and 8 weeks
IPSS storage subscore
Changes of IPSS storage subscore at 1, 2, 4 and 8 weeks after treatment compared with baseline
Time frame: 1, 2, 4 and 8 weeks
IPSS voiding subscore
Changes of IPSS voiding subscore at 1, 2, 4 and 8 weeks after treatment compared with baseline
Time frame: 1, 2, 4 and 8 weeks
IPSS total score severity
Proportion of patients with IPSS total score severity decreased by at least one grade 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: week 12
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
Maximum urinary flow rate (Qmax)
The change of Qmax at the 12th week of treatment compared with baseline.
Time frame: week 12
Residual urine volume (PVR)
The change of PVR at the 12th week of treatment compared with baseline.
Time frame: week 12
Prostate specific antigen (PSA)
The change of PSA at the 12th week of treatment compared with baseline.
Time frame: week 12
Prostate volume (PV)
Changes of PV at 12 the 12th week of treatment compared with baseline.
Time frame: week 12
Responder rate
Responder rate is defined as the proportion of patients whose IPSS total score decreased by ≥ 25% and Qmax increased by ≥ 30% compared with baseline value after treatment.
Time frame: week 12
Proportion of patients with BPH clinical progression
Clinical progress is defined as the first occurrence of one of the following two conditions during the trial: 1. Acute urinary retention (AUR); 2. Clinical diagnosis requires surgical treatment of BPH.
Time frame: week 12
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