What is the mechanism of action of this treatment?

Compression stockings work by preventing blood from pooling in the legs, which reduces the amount of fluid that shifts to the bladder at night, thereby decreasing nocturia events. This is important for nocturia patients as it addresses one of the underlying causes of their condition—fluid redistribution. Other treatments, such as medications that reduce nighttime urine production and behavioral interventions to limit fluid intake before bedtime, also play a significant role in managing nocturia. These treatments are essential as they directly target the symptoms, improving the quality of life for patients suffering from nocturia.

What side effects are associated with this type of intervention?

Compression stockings, used to prevent blood pooling in the legs and reduce nocturia, are generally well-tolerated with minimal side effects. Some individuals may experience discomfort, skin irritation, or allergic reactions to the material. Other non-pharmacologic treatments for nocturia, such as lifestyle modifications and fluid management, typically have few side effects but may require significant behavioral changes. Overall, these treatments are considered safe and effective for managing nocturia.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for nocturia that are similar to the use of compression stockings for preventing blood pooling in the legs in the provided context. However, nocturia management often involves lifestyle modifications, behavioral therapies, and pharmacologic treatments aimed at underlying causes such as overactive bladder or heart failure. Compression stockings are being studied for their potential to reduce nocturia by preventing blood from pooling in the legs, which may help reduce nighttime urination.

What other types of research exist?

Promising novel alternatives to compression stockings for preventing blood pooling in the legs of nocturia patients include intermittent pneumatic compression devices and advanced pneumatic compression therapy. These methods have shown effectiveness in improving quality of life and managing lymphedema, which may translate to benefits in nocturia management by preventing blood pooling.

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Compression Stockings for Nocturia

N/A

Waitlist Available

Led By John Maesaka, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age above or equal to 18 years at the time of signing informed consent

Be older than 18 years old

Must not have

Local skin or soft-tissue condition, including recent skin graft, gangrene, oozing dermatitis and severe cellulitis

Leg edema or pulmonary edema from congestive heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, day 11-20 visit, day 21-30 visit

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if special socks that squeeze your legs can help people who often wake up at night to urinate. The socks may help by improving blood flow and reducing fluid buildup in the legs.

Who is the study for?

This trial is for adults over 18 who can sign a consent form and follow the study plan. It's not for people with poor blood flow in their legs, severe nerve damage, allergies to stocking materials, skin conditions on the leg, abnormal leg shape/size, heart-related swelling or those taking water pills.

What is being tested?

The study tests if wearing compression stockings can reduce body weight changes from morning to night and lessen nocturia events by preventing blood pooling in legs. Participants' views on how nocturia impacts their lives will also be collected.

What are the potential side effects?

Compression stockings are generally safe but may cause discomfort, skin irritation or marks, warmth in the legs, and rarely worsen existing skin conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious skin or soft-tissue condition.

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I have swelling in my legs or lungs due to heart failure.

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I have or might have peripheral arterial disease, or I've had surgery for it.

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I am currently taking diuretics like furosemide or hydrochlorothiazide.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, day 11-20 visit, day 21-30 visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, day 11-20 visit, day 21-30 visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 11-20 visit, day 21-30 visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the level of nocturia

Change in the quality of life for people with nocturia

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Study GroupExperimental Treatment1 Intervention

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.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Compression stockings work by preventing blood from pooling in the legs, which reduces the amount of fluid that shifts to the bladder at night, thereby decreasing nocturia events. This is important for nocturia patients as it addresses one of the underlying causes of their condition—fluid redistribution. Other treatments, such as medications that reduce nighttime urine production and behavioral interventions to limit fluid intake before bedtime, also play a significant role in managing nocturia. These treatments are essential as they directly target the symptoms, improving the quality of life for patients suffering from nocturia.