Nocturia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Graduated compression stockings (GCS) are used to treat chronic venous diseases and edema. They help to improve blood flow and prevent blood pooling in the legs. The use of GCS will be in accordance with this indication. The greatest pressure is exerted at the ankle with gradually decreasing pressures up the length of the stockings. GCS are designed for use out of bed and are manufactured using strict medical and technical specifications.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the level of nocturia | 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 | 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. |
Countries
United States
Outcome results
None listed