NCT00710749已完成不适用
An Open Prospective Multicenter Study Comparing the Urine Flow Measurements of Standard Clinic Flow Measurements vs Comercially Available Portable Digital Flow Meters and a Disposable Flow Meter in a Crossover and Randomized Order on Male BPH Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- Mean Urine Flow Rate
研究概览
简要总结
Crossover comparison of different flow meters with a digital home flow meter as a reference. Main hypothesis: Reapeated home flow measurements with a disposable device will provide a better understanding of the patients urinary flow than a single measurement performed in the clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent
- •Males aged 45-85 years
- •>60% of the voiding volume is above 100 ml per voiding verified by a urinary diary
- •Able to read write and understand given instructions
排除标准
- •Patients practicing CIC
- •Ongoing symptomatic UTI
- •Known Neurological Disease that is affecting the bladder function
- •Known past or present alcohol or drug abuse
- •Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
- •Previous enrolment or randomisation of treatment in the present study.
- •Suspected poor compliance based on less than 80 % compliance to voiding diary
- •Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
- •On alpha-blocker or 5-alpha reductase inhibitor treatment, treatment started less than 2 months prior to enrolment
- •Clinic flow below 100 ml
结局指标
主要结局
Mean Urine Flow Rate
时间窗: At every voiding event during approximately one week.
Measurements with a disposable device and the current clinic gold standard measurement were compared to test the hypothesis that three repeated measurements with the disposable device was as accurate as one clinic flow measurement. A digital device was used as a reference of the most exact way to evaluate each patient's individual flow.
次要结局
未报告次要终点
研究者
研究点 (8)
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