Pathophysiologic Study to Understand and Possibly Treat Nocturia

NCT05298384 | Withdrawn

• 1 other identifier: 21-00542
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Nocturia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Other: Compression stockings

Interventions

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.

Study Group

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Nocturia

Interventions

Stockings, Compression

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Compression Bandages; Bandages; Equipment and Supplies

Study Officials

• John Maesaka, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 28, 2022
• Study Start: August 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.

Locations

US (1)