Pathophysiologic Study to Understand and Possibly Treat Nocturia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in the level of nocturia
研究概览
简要总结
This study will mainly look at how well compression stockings decrease body weight between morning and night and the number of nocturia events, by preventing blood from pooling in your legs. Also, this research study is being done to collect the thoughts/reactions/opinions on how nocturia affects the life of one who suffers from nocturia.
详细描述
This study intends to investigate the different causes nocturia. Patients with nocturia will be assigned to wearing knee high then thigh high compression stockings to assess the effect on weight gain during the day and the number of nocturia events. Renin and aldosterone levels will also be assessed. Furthermore, fluorescein dye will be used to to demonstrate vascular leakage of the fluorescent dye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above or equal to 18 years at the time of signing informed consent
- •Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- •Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study prior to initiation of any protocol-mandated procedures.
排除标准
- •Suspected or proven peripheral arterial disease, including history of peripheral arterial bypass grafting
- •Any sensory impairment such as severe peripheral neuropathy as evidenced by patient reported intermittent claudication and/or signs of ischemia such as "blue toes".
- •Allergy to stocking textile material.
- •Leg edema or pulmonary edema from congestive heart failure.
- •Local skin or soft-tissue condition, including recent skin graft, gangrene, oozing dermatitis and severe cellulitis.
- •Extreme deformity of the leg, or unusual leg shape or size that would prevent correct fit.
- •Treatment with any diuretics such as furosemide or hydrochlorothiazide.
结局指标
主要结局
Change in the level of nocturia
时间窗: Baseline, Day 11-20 visit, Day 21-30 visit
To measure the reduction of nocturia by the absolute change in body weight between morning and night and nocturia events at baseline and after compression stocking use.
Change in the quality of life for people with nocturia
时间窗: Baseline visit, Day 20 visit
To measure the effect of nocturia on Quality of Life by the percent change in QOL score when comparing baseline and 20 days of treatment with compression stockings.
次要结局
未报告次要终点