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临床试验/NCT02245334
NCT02245334Unknown4 期

A Prospective Randomized Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 1,578 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
1,578
试验地点
1
主要终点
Number of participants with febrile infection

研究概览

简要总结

To assess the effect of povidone-iodine on infectious complication rate caused by transrectal prostate biopsy

详细描述

the effect of povidone-iodine on infectious complication rate caused by transrectal prostate biopsy

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • who undergo transrectal prostate biopsy

排除标准

  • patients who refuse to be included, patients who have hypersensitivity to iodine, patients who have abnormal thyroid function, patients who do not visit follow-up, patients who have received prior radioactive-iodine therapy

研究组 & 干预措施

Povidone-iodine

Experimental

povidone iodine pill

干预措施: Povidone-Iodine (Drug)

结局指标

主要结局

Number of participants with febrile infection

时间窗: 1 week

consider fever over 38 degree celsius or admission due to fever

次要结局

  • voiding questionnaire(1-2 week)
  • sexual function questionnaire(1-2 week)
  • quality of life questionnaire(1-2 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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