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临床试验/NCT00037141
NCT00037141已完成1 期

Evaluation of the Safety and Tolerability of Transurethral Alcohol Injection for the Treatment of BPH (Enlarged Prostate)

American Medical Systems0 个研究点目标入组 150 人开始时间: 2002年3月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
150

研究概览

简要总结

Multi-center, prospective randomized dosing and safety research study. A maximum of 150 men will be enrolled in the study. Qualifying patients will receive one of three possible doses of the study drug. Symptoms will be evaluated before treatment, and then 1-week, 1-month, 3-months, and 6-months following treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment

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

  • •Eligible patients are 50 to 80-year-old men who have experienced some or all of the following urinary symptoms for at least 6 months:
  • •frequent or urgent need to urinate
  • •difficulty starting their urinary stream
  • •interruption of their urinary stream
  • •feeling of incomplete emptying of bladder after urinating
  • •interruption of sleep due to the urge to urinate
  • •Patients should have tried oral medication for their condition in the past, and be willing to discontinue any current BPH medications for a period of time before undergoing study treatment. They should be in good general health and have no previous surgery, or other procedure(s) intended to reduce prostate size.

排除标准

  • 未提供

研究者

申办方类型
Industry

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