Discovering the Effect of Venous Insufficiency on Nocturia: a Prospective, Controlled Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change of micturition frequency
研究概览
简要总结
With this prospective controlled trial, we hope to obtain more information about the coexistence between venous insufficiency and nocturia.
In our opinion, venous insufficiency (CEAP 2-3a) leads to an increase in fluid accumulation in the lower limbs due to moving around all day. When laying down during nighttime, this fluid is reabsorbed into the systimic fluid pool, leading to an increase in diuresis and thus an increase in nocturnal voiding. Aim of this study is observe difference in nocturnal frequency and urine production before and after surgical treatment of venous insufficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CEAP 2 till 4A
排除标准
- •BMI higher than 30
- •Previous surgery due to venous insufficiency at the lower limbs
- •Cronic edema (Cronic heart failure, liver cirrosis, nefrotic syndrome)
- •Pregnant patient
- •Patients on the following medication: Calcium-antagonists, lithium, NSAID's or corticosteroids, glitazones, insuline, diuretics, sartans, ACE-inhibitors, desmopressine,
研究组 & 干预措施
<2 nocturnal voids
All interventions in this group are done twice: Once before surgical intervention, and once 2 months after surgical intervention
- Complete a 3 day Frequency Volume chart
- Questionnaires: ICIG FLUTS/MLUTS, PSQI and CIVIQ2
干预措施: Questionnaires (Other)
<2 nocturnal voids
All interventions in this group are done twice: Once before surgical intervention, and once 2 months after surgical intervention
- Complete a 3 day Frequency Volume chart
- Questionnaires: ICIG FLUTS/MLUTS, PSQI and CIVIQ2
干预措施: Frequency Volume Chart (Diagnostic Test)
=> 2 nocturnal voids
All interventions in this group are done twice: Once before surgical intervention, and once 2 months after surgical intervention
- Complete a 3 day Frequency Volume chart and collection of the urine of the last day and night to complete osmolality and sodium testing.
- Measuring the circumference off the lower limbs just after awakining and before falling asleep
- Questionnaires: ICIG FLUTS/MLUTS, PSQI and CIVIQ2
干预措施: Questionnaires (Other)
=> 2 nocturnal voids
All interventions in this group are done twice: Once before surgical intervention, and once 2 months after surgical intervention
- Complete a 3 day Frequency Volume chart and collection of the urine of the last day and night to complete osmolality and sodium testing.
- Measuring the circumference off the lower limbs just after awakining and before falling asleep
- Questionnaires: ICIG FLUTS/MLUTS, PSQI and CIVIQ2
干预措施: Frequency Volume Chart (Diagnostic Test)
=> 2 nocturnal voids
All interventions in this group are done twice: Once before surgical intervention, and once 2 months after surgical intervention
- Complete a 3 day Frequency Volume chart and collection of the urine of the last day and night to complete osmolality and sodium testing.
- Measuring the circumference off the lower limbs just after awakining and before falling asleep
- Questionnaires: ICIG FLUTS/MLUTS, PSQI and CIVIQ2
干预措施: Collect urine during 1 day (Diagnostic Test)
=> 2 nocturnal voids
All interventions in this group are done twice: Once before surgical intervention, and once 2 months after surgical intervention
- Complete a 3 day Frequency Volume chart and collection of the urine of the last day and night to complete osmolality and sodium testing.
- Measuring the circumference off the lower limbs just after awakining and before falling asleep
- Questionnaires: ICIG FLUTS/MLUTS, PSQI and CIVIQ2
干预措施: Blood sample (Diagnostic Test)
=> 2 nocturnal voids
All interventions in this group are done twice: Once before surgical intervention, and once 2 months after surgical intervention
- Complete a 3 day Frequency Volume chart and collection of the urine of the last day and night to complete osmolality and sodium testing.
- Measuring the circumference off the lower limbs just after awakining and before falling asleep
- Questionnaires: ICIG FLUTS/MLUTS, PSQI and CIVIQ2
干预措施: Measurement of the circumference of the lower legs (Diagnostic Test)
结局指标
主要结局
Change of micturition frequency
时间窗: 2 months after surgery
Change of the micturition frequency with 1 void
次要结局
- Change in nocturnal diuresis(2 months after surgery)