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Study closed prior to enrollment of participants.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Individuals with nocturia as a result of idiopathic edema and autonomic failure 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compression stockings | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the level of nocturia | 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. | Baseline, Day 11-20 visit, Day 21-30 visit |
| Change in the quality of life for people with nocturia | 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. | Baseline visit, Day 20 visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Maesaka, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to John.Maesaka@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D053158 | Nocturia |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D053828 | Stockings, Compression |
| ID | Term |
|---|---|
| D058128 | Compression Bandages |
| D001458 | Bandages |
| D004864 | Equipment and Supplies |
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