An interventional study of Compression stockings in Nocturia, sponsored by NYU Langone Health. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2024-09-26.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Diagnostic
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.
134 studies on the registry are indexed under Nocturia; 22 are open to participants now.
Browse Nocturia studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Compression stockings
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.
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.
Time frame: 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.
Time frame: Baseline visit, Day 20 visit
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access criteria: 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.
No publications or documents are linked to this record.
This study is withdrawn, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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