Pathophysiologic Study to Understand and Possibly Treat Nocturia

NYU Langone Health

Status: Withdrawn

Conditions: Nocturia

Treatments: Other: Compression stockings

Study type: Interventional

Funder types: Other

Identifiers

NCT05298384

21-00542

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Study Group

Experimental group

Description:

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.

Treatment:

Other: Compression stockings