The Efficacy and Safety of Qianweitai (Silodosin Capsule) Versus Tamsulosin in the Treatment of BPH

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.

• Silodosin (Drug), also known as Qianweitai: 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.
• Tamsolusin (Drug), also known as Harnal: 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.

Primary outcomes

• International Prostate Symptom Score（IPSS） [week 12]: Changes of IPSS scores at the 12th week of treatment compared with baseline scores.

Secondary outcomes

• International Prostate Symptom Score（IPSS） total score [1, 2, 4 and 8 weeks]: Changes of IPSS scores at 1, 2, 4 and 8 weeks after treatment compared with baseline
• IPSS storage subscore [1, 2, 4 and 8 weeks]: Changes of IPSS storage subscore at 1, 2, 4 and 8 weeks after treatment compared with baseline
• IPSS voiding subscore [1, 2, 4 and 8 weeks]: Changes of IPSS voiding subscore at 1, 2, 4 and 8 weeks after treatment compared with baseline
• IPSS total score severity [week 12]: 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).
• Quality of life (QoL) score [4, 8 and 12 weeks]: 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.
• Maximum urinary flow rate (Qmax) [week 12]: The change of Qmax at the 12th week of treatment compared with baseline.
• Residual urine volume (PVR) [week 12]: The change of PVR at the 12th week of treatment compared with baseline.
• Prostate specific antigen (PSA) [week 12]: The change of PSA at the 12th week of treatment compared with baseline.
• Prostate volume (PV) [week 12]: Changes of PV at 12 the 12th week of treatment compared with baseline.
• Responder rate [week 12]: 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.
• Proportion of patients with BPH clinical progression [week 12]: 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.

Sex: Male, ages: 60 Years to 80 Years

Inclusion Criteria:

1. Male Subjects aged 60 ～ 80 years, clinically diagnosed as benign prostatic hyperplasia.
2. Has an IPSS score ≥ 8 points at Screening and Baseline.
3. Has a 4 ≤ Qmax ≤ 15 ml/s when urination volume > 150 ml.
4. Has a prostate volume (PV) ≥ 30 ml by ultrasound examination.
5. Subjects who can read, understand, and complete the research questionnaire.
6. Subjects willing to participate voluntarily in this clinical trial, give informed consent and sign informed consent.

Exclusion Criteria:

1. Subjects with prostate cancer or other malignant tumors.
2. Subjects have serum tPSA > 10ng/ml, or 4 ≤ tPSA ≤ 10ng/ml while fPSA/tPSA < 0.16 times.
3. Subjects suffered from other diseases causing dysuria, such as bladder neck spasm, urethral stricture, neurogenic bladder dysfunction, etc.
4. Subjects have suffered from acute urinary retention, or complicated with gross hematuria, urinary tract infection, bladder stones, secondary upper urinary tract hydronephrosis, urinary incontinence, renal insufficiency and other Subjects that researchers believe meet the surgical indications.
5. Subjects have undergone prostate surgery, microwave therapy, urethral dilatation or acute urinary retention catheterization or other invasive procedures.
6. Subjects have residual urine volume (PVR) > 100ml, or those who may have urinary retention and need catheterization.
7. Subjects who took α receptor blockers, traditional Chinese medicine or botanical drugs for treating BPH within two weeks before participating this clinical trial.
8. Subjects who take 5α reductase inhibitor or other antiandrogen therapy drugs within half a year before participating this clinical trial.
9. Subjects who need to take drugs prohibited in this study or adopt prohibited treatment methods during treatment.
10. Subjects who Complicated with severe cardiovascular and cerebrovascular diseases, respiratory diseases, blood diseases, liver and kidney diseases.
11. There are significant abnormalities in clinical or laboratory examination indexes of patients, such as ALT and AST ≥ 2.5 times of the upper limit of reference value, creatinine (Scr) > 1.5 times of the upper limit of reference value, or poor blood glucose control (fasting blood glucose FPG ≥ 10 mmol/L).
12. Subjects who are allergic to the drugs or ingredients used in the test definitely.
13. Any otherSubjects in the opinion of researchers is not suitable for inclusion.

• Shan Chen, Principal investigator, Beijing Tongren Hospital