NCT00687388撤回4 期
The Clinical Efficacy of Non-steroidal Anti-inflammation Drugs in Patients With Benign Prostatic Hyperplasia: A Prospective Randomized Multicenter Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- The changes of International Prostatic Symptom Scores after medications
研究概览
简要总结
Non-steroidal Anti-inflammation Drugs can effectively reduce the lower urinary tract symptoms from benign prostatic hyperplasia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Who had the treatment of BPH with alpha-1 blockers for more than 3 months
- •Who have the IPSS(International Prostatic Symptom Score) >= 15
- •Who have the maximum flow rate(Qmax) < 15 with voided volume > 150mL
- •Who have the PPBC(patient's perception of bladder condition) >= 3 (The PPBC was assessed by the use of a six point ordered categorical scale(1-6 point). The higher score means the higher bother)
- •Who had the PSA level < 4 ng/mL within 6 months (But, the patient who are revealed not to have prostate cancer by prostate biopsy can be included even if he had PSA level of 4-10 ng/mL)
- •Who underwent the transrectal ultrasound of prostate within 6 months
- •Who can understand this study and can give the informed consent
排除标准
- •Who had regular intake of 5-alpha reductase inhibitor or NSAID within 6 months before screening
- •Who have peptic ulcer and/or asthma
- •Who have urologic malignancies such as prostate cancer and bladder cancer
- •Who have urethral strictures, large bladder diverticuli, and bladder neck contractures
- •Who had surgical treatment for BPH
- •Who have histories of bladder and/or urethra
- •Who have serum PSA level more than 10 ng/ml
- •Who have histories of orthostatic hypotension
- •Who have serum creatinine level more than 2.0 mg/dl
- •Who have serum ALT and/or AST level more than 1.5 times of normal upper limit
- •Who have heart failure
- •Who have histories of bacterial prostatitis within 1 year
- •Who have histories of active urinary tract infection within 1 month
- •Who have histories of the biopsy of bladder and prostate within 1 month
- •Who are unable to void
- •Who use pads because of incontinences
- •Who have hypersensitivities for alpha blockers that include quinazoline, NSAID, aspirin, sulfonamide
- •Who have histories of unstable angina, myocardial infarction, and cerebrovascular accident within 6 months
- •Who have neurogenic bladder due to multiple sclerosis, Parkinson's disease, Spinal injuries and etc.
- •Who have thinking disturbances
- •Who have histories of abuses of alcohol and/or other drugs
- •Who seem to be not fit to this study by the decision of investigators
研究组 & 干预措施
Alpha-blocker
Active Comparator
Alpha-blocker only
干预措施: selective alpha 1-blockers (Drug)
NSAID
Active Comparator
NSAID only
干预措施: celecoxib (Drug)
alpha-blocker and NSAID
Experimental
Combination treatment of alpha-blocker and NSAID
干预措施: alpha-blocker and NSAID (Drug)
结局指标
主要结局
The changes of International Prostatic Symptom Scores after medications
时间窗: 8 weeks
次要结局
- The changes of voiding frequencies after medications(8 weeks)
- The changes of 'ICS male questionnaire-short form' after medications(8 weeks)
- Patient perception of treatment benefit questionnaire(8 weeks)
- The changes of 'patient perception of bladder condition' after medications(8 weeks)
- The changes of maximum flow rate and postvoid residuals after medications(8 weeks)
- The changes of serum PSA levels after medications(8 weeks)
- The changes of WBC counts on the expressed prostatic secretions after medications(8 weeks)
- Complications(During all study periods)
研究者
KYU-SUNG LEE
Professor
Samsung Medical Center
研究点 (3)
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