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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qianweitai | Experimental | Patients orally take Qianweitai (silodosin capsule), 4mg/capsule, 1 capsule/time, bid, after breakfast and dinner). |
|
| Tamsulosin | Active Comparator | Patients orally take tamsulosin hydrochloride capsules (1 tablet each time, once daily). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silodosin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| International Prostate Symptom Score(IPSS) | Changes of IPSS scores at the 12th week of treatment compared with baseline scores. | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| International Prostate Symptom Score(IPSS) total score | Changes of IPSS scores at 1, 2, 4 and 8 weeks after treatment compared with baseline | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shan Chen | Beijing Tongren Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | China | |||
| Wuhan Center Hospital |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C095285 | silodosin |
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| Tamsolusin | Drug | 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. |
|
|
| 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 | 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). | 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. | 4, 8 and 12 weeks |
| Maximum urinary flow rate (Qmax) | The change of Qmax at the 12th week of treatment compared with baseline. | week 12 |
| Residual urine volume (PVR) | The change of PVR at the 12th week of treatment compared with baseline. | week 12 |
| Prostate specific antigen (PSA) | The change of PSA at the 12th week of treatment compared with baseline. | week 12 |
| Prostate volume (PV) | Changes of PV at 12 the 12th week of treatment compared with baseline. | 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. | 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:
| week 12 |
| 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 |
| D052801 |
| Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |