Neurophysiological Assessment of Healthy and Impaired Human Lower Urinary Tract Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- N1latency of LUT SEPs
研究概览
简要总结
Study part 1 will consist of sensory evoked cortical potential (SEP) measurements of the lower urinary tract (LUT) in healthy subjects using different stimulation frequencies from 0.25 to 3Hz to find the most effective frequency in regard to acquisition time for reliable SEP response rates. Study part 2 will consist of a series of consecutive SEP measurements in patients with LUT symptoms during low bladder volume and maximum cystometric capacity to assess reliability of measurements and influence of potential concomitant LUTS treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers:
- •Written informed consent,
- •good mental and physical health,
- •age >18y,
- •Patients with LUTS and Patients with LUTS and treatment:
- •Written informed consent,
- •age >18y,
- •prior urodynamic investigation,
- •LUTS since >6months with or without detrusor overactivity
排除标准
- •healthy volunteers:
- •any neurological or urological pathology,
- •current pregnancy or lactation,
- •urinary tract infection,
- •hematuria,
- •any previous pelvic or spine or craniocerebral surgery,
- •any anatomical anomaly of the LUT or genitalia,
- •any metabolic disease,
- •any LUT malignancy,
- •bladder capacity <150mL,
- •SDV at 60mL;
- •Patients with LUTS and Patients with LUTS and treatment:
- •current pregnancy or lactation,
- •urinary tract infection,
- •gross hematuria
研究组 & 干预措施
Patients with LUTS and treatment
Patients with LUTS and treatment
干预措施: EEG and EP measurement (Procedure)
Healthy volunteers
Healthy volunteers
干预措施: EEG and EP measurement (Procedure)
Patients with LUTS
Patients with LUTS
干预措施: EEG and EP measurement (Procedure)
结局指标
主要结局
N1latency of LUT SEPs
时间窗: 2-3 measurements within 4-16 weeks from first exam
次要结局
未报告次要终点