Back to resultsPathophysiologic Study to Understand and Possibly Treat Nocturia
Primary Purpose
Nocturia
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compression stockings
Sponsored by
About this trial
This is an interventional diagnostic trial for Nocturia
Eligibility Criteria
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.
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Group
Arm 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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05298384
Brief Title
Pathophysiologic Study to Understand and Possibly Treat Nocturia
Official Title
Pathophysiologic Study to Understand and Possibly Treat Nocturia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Compression stockings
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the level of nocturia
Description
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
Title
Change in the quality of life for people with nocturia
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Maesaka, MD
Phone
516-663-2169
Email
John.Maesaka@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Maesaka, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Maesaka, MD
Phone
516-663-2169
Email
john.maesaka@nyulangone.org
First Name & Middle Initial & Last Name & Degree
John Maesaka, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing 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.
IPD Sharing 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.
Learn more about this trial
Pathophysiologic Study to Understand and Possibly Treat Nocturia
We'll reach out to this number within 24 hrs