KCT0000077招募中未知
Comparative Study on the Efficacy and Safety of Initial Combination Therapy of Low Dose Propiverine Hydrocholoride Compared to Alpha-antagonist Monotherapy in men with BPH with Overactive bladder: A Prospective Placebo Controlled Study
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 236
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 45(Year) 至 o Limit（—）
- 性别
- Male
入选标准
- •1. signed Informed consent form
- •2. Male aged more than 45
- •3. IPSS more than 12
- •4. Enlarged prostate on DRE
- •5. Symptoms of urinary urgency with voiding 3/day
- •6. Symptoms of urinary frequency (8 micturitions per 24 hours)
- •7. Symptoms of LUTS more than 3 months
- •8. understanding and agreed the purpose of trial
排除标准
- •1. Total daily urine volume of > 3000 ml
- •2. Initial RU more than 150ml
- •3. Significant hepatic or renal disease
- •(twice the upper limit of the reference ranges for serum concentrations of AST [SGOT], ALT [SGPT], alkaline phosphatase or creatinine)
- •4. Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
- •5. Symptomatic acute urinary tract infection (UTI) during the run-in period
- •6. Recurrent UTIs defined as having been treated for symptomatic UTIs > 4 times in the last year
- •7. Diagnosed or suspected interstitial cystitis
- •8. Clinically significant hematuria or hematuria secondary to malignant disease.
- •9. PSA more than 10ng/dl (can include PSA between 4 and 10 if biopsy is negative)
- •10. Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with any anticholinergic drugs other than randomized trial drug
- •11. Receipt of any electrostimulation or bladder training within the 14 days before randomization, or expected to start such treatment during the study
- •12. An indwelling catheter or practicing intermittent self-catheterization
- •13. Use of any investigational drug within 2 months preceding the start of the study
- •14. Patients with chronic constipation or history of severe constipation
- •15. Patients who have bladder cancer or prostate cancer
- •16. History of bladder and prostate surgery
- •17. suspicious prostatitis
- •18. suspicious neurogenic bladder
- •19. Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
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