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临床试验/NCT01663181
NCT01663181已完成不适用

Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2009年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
109
试验地点
1
主要终点
subjective pain perception immediately after examination as measured by a standard visual analog scale

研究概览

简要总结

At an academic tertiary referral center, patients with pelvic floor dysfunction, scheduled for outpatient cystoscopy or urodynamic testing will be asked to participate in the study. Patients will be called one day after the examination and will be asked about pain and their general state of health.

The purpose of this study it to investigate pain perception in urogynecologic patients during outpatient cystoscopy and compare it with pain perception during outpatient urodynamic. The investigators will also investigate the difference between anticipated and actual pain perception. The investigators will test the null hypothesis that there is no difference in patients´ pain perception between outpatient cystoscopy and urodynamic testing. The secondary hypothesis will be that there is no difference between patients´ anticipated amount of pain and the actually experienced pain during cystoscopy and urodynamic testing.

According to power calculation, a sample size of 52 patients per group will be needed to detect a 2 cm difference in pain scores on the VAS - judged as a clinically significant difference - with 95% power and a two-sided significance level of 0.05.

Exclusion criteria are: age ≤ 18 years, insufficient ability to understand German, pregnancy and the participation in another clinical study at the same time.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • women undergoing cystoscopy or urodynamic testing at an academic tertiary referral center.

排除标准

  • age ≤ 18 years
  • insufficient ability to understand German
  • pregnancy
  • participation in another clinical study at the same time

结局指标

主要结局

subjective pain perception immediately after examination as measured by a standard visual analog scale

时间窗: immediately after examination (zero to ten minutes after completing cystoscopy or urodynamics)

patients are assessed at three points in time: 1. zero to ten minutes before undergoing examination 2. zero to ten minutes after undergoing examination 3. 24 hours after undergoing examination

次要结局

  • difference between anticipated pain and actual pain perception(immediately before and immediately after the examination (zero to ten minutes after undergoing examination))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wolfgang Umek, MD

ao.Univ.Prof.Dr.univ.med

Medical University of Vienna

研究点 (1)

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