NocturiaNCT05298384
Pathophysiologic Study to Understand and Possibly Treat Nocturia
A study testing Compression stockings in people with Nocturia, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Nocturia
- What is being tested?
- Compression stockings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2024to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Nocturia
- Being tested
- Compression stockings
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression stockingsOther
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 | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Compression stockings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline visit, Day 20 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study startAug 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionNov 2024 (estimated)
Why it stopped: Study closed prior to enrollment of participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NocturiaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Maesaka, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298384
- Sponsor's protocol ID
- 21-00542
- Status last verified
- Sep 2024
- First submitted
- 18 Mar 2022
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiologic Study to Understand and Possibly Treat Nocturia
- ClinicalTrials.gov ID
- NCT05298384
- Acronym / sponsor ID
- 21-00542
- Conditions
- Nocturia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study closed prior to enrollment of participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Compression stockingsIndividuals 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. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression stockingsGraduated 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. | Other | Study Group |
Primary outcome
Change in the level of nocturia
Time frame: 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
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Maesaka, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression stockings in people with Nocturia, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the level of nocturia (time frame: Baseline, Day 11-20 visit, Day 21-30 visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.