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临床试验/NCT03614767
NCT03614767Unknown不适用

Assessment of Predictive Role of Urodynamics in Sacral Neuromodulation Patients

Universiteit Antwerpen1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Change in bladder sensation

研究概览

简要总结

In the field of urology, sacral neuromodulation (SNM) is a well-accepted, second-line, minimally invasive treatment for patients with overactive bladder dry (OABD) or wet (OABW), and for patients with non-obstructive urinary retention (NOUR).

Long-term vary between 50-60%. This study examines whether urodynamics can be used as a predictor for successful SNM therapy

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
All
接受健康志愿者

入选标准

  • Overactive bladder
  • Non-obstructive urinary retention

排除标准

  • Neurogenica disorder (e.g. cerebrovascular accident, spinal cord injury)

结局指标

主要结局

Change in bladder sensation

时间窗: 3 weeks

Bladder sensation is measured by a slider (indicating bladder fullness scaled from 0 to 100) before and after test procedure for sacral neuromodulation

Change in bladder volume

时间窗: 3 weeks

Change in bladder volume is measured before and after test procedure for sacral neuromodulation

Change in ice water test

时间窗: 3 weeks

Ice water is infused in the bladder and incontinence upon insertion of the ice water is assessed before and after sacral neuromodulation

次要结局

未报告次要终点

研究者

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

Donald Vaganée

Principal Investigator

Universiteit Antwerpen

研究点 (1)

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