Pathophysiologic Study to Understand and Possibly Treat Nocturia

Not Applicable

Not yet recruiting

• Conditions: Nocturia
• Interventions: Other: Compression stockings

• Registration Number: NCT05298384
• Lead Sponsor: NYU Langone Health

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.

Study Timeline

• Study First Submitted: 2022-03-18
• Study First Submitted QC: 2022-03-18
• Study First Posted: 2022-03-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13
• Study Start: 2024-08
• Primary Completion: 2024-10
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Group	Compression stockings	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States