EUCTR2004-000871-33-CZ进行中（未招募）不适用
Propiverine hydrochloride extended release (ER): Tolerability in patients with LUTS and BPS/BPHA randomised, double-blind, placebo-controlled, multi-centre clinical trial - not applicable
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •- Male patients with Lower Urinary Tract Symptoms
- •- Residual urine in a range of 30 - 80 ml
- •- Urinary stream in a range of 10 - 18 ml/s
- •- IPSS Score in a range of 8 - 17
- •- Micturition volume 150 - 600 ml
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Prostate cancer (PSA > 4 ng/ml, unless negative prostate biopsy within last 12 months)
- •- Acute urinary tract infection (=10^5 bacteria/ml urine, acute history of urinary tract infection within 3 months)
- •- Medication: 5 alpha reductase inhibitor, alpha blocker, phytotherapy for BPS/BPH
- •- Concomitant medication known to interfere with the trial medication or the goals of the trial
- •- Indwelling urinary catheter
- •- Diseases or congenital anomalies of the nervous system (e.g. neurological musculo-sceletal disorders, spina bifida)
- •- Anomalies of the lower genitourinary tract (e.g. fistulas, urethral stricture, etc.)
研究者
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