Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
Conditions
Keywords
Benign Prostatic Hyperplasia Silodosin Capsules, Silodosin
Brief summary
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.
Detailed description
Sample size: 108
Interventions
DRUGSilodosin Capsules
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.
DRUGTamsulosin
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.
Sponsors
Xintian Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Group A: Oral Tamsulosin Hydrochloride Capsules for 12 weeks. Group B: Oral l Silodosin Capsules for 12 weeks.
Eligibility
Sex/Gender
MALE
Age
60 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Prostate Symptom Score（IPSS） | 12 week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 scores. The scores of the scale ranged from 0 to 35. The higher the score, the more severe the symptoms are. |
| IPSS Stimulus score | 12 weeks | 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. |
| IPSS obstruction score | 12 weeks | 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. |
| IPSS total score severity | 12 week | 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). |
| 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) | 12 weeks | The change of Qmax at 12 weeks of treatment compared with baseline. |
| Residual urine volume (PVR) | 12 weeks | Changes of PVR at 12 weeks of treatment compared with baseline. |
| Patient response rate | 12 weeks | Patient response rate is defined as the proportion of patients whose IPSS total score decreased by ≥ 25% compared with baseline value after treatment. |
Countries
China
Contacts
STUDY_CHAIRZhongguo Chen, MD
employee
Outcome results
None listed