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Study of Idiopathic Edema

This study has been completed.
Information provided by (Responsible Party):
John Maesaka, MD, Winthrop University Hospital Identifier:
First received: August 8, 2012
Last updated: November 2, 2016
Last verified: November 2016

Idiopathic edema (IE) is an ill-defined syndrome of uncertain etiology that occurs virtually exclusively in women. It has also been referred to as cyclical edema, periodic edema, fluid retention syndrome and orthostatic edema.

The present studies were designed to 1. Improve our ability to identify patients with idiopathic edema by extending the clinical criteria from an increase in weight of > 1.4 kg between 8 AM to 10 PM to the inclusion of nocturia, a very important component to the history. Additional aims are to: 2. Demonstrate orthostatic weight gain with or without edema in idiopathic edema and autonomic failure that will identify a greater number of patients suffering from variable degrees of weight gain and compare to controls or other conditions associated with edema. The study will focus mainly on subjects with polycystic ovaries and autonomic failure. 3. Provide a reasonable course of therapy that is presently not well defined. 4. Provide evidence that orthostatic edema or weight gain has two common etiologies, a. an increase in vascular membrane as in idiopathic edema and b. pooling of blood in the lower extremities in autonomic failure due to a lack of vascular tone.

Idiopathic Edema Nocturia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of Idiopathic Edema

Resource links provided by NLM:

Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • Orthostatic weight exceeding 1.4 kg/day [ Time Frame: 1 day ]
    the subject will record weights upon arising and before retiring at night.

Secondary Outcome Measures:
  • Nocturia [ Time Frame: overnight ]
    The subject will record and save all urines excreted after retiring for the night and upon arising in the morning.

Enrollment: 4
Study Start Date: September 2011
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
1.4kg wt gain 8AM -10 PM
Complete a questionnaire. Measure and record weight in AM and PM.Record for one week,number of times urinated after bedtime and before waking up.
>1.4kg wt gain 8AM - 10PM no nocturia.
Complete a questionnaire. Measure and record weight in AM and PM.Record for one week,number of times urinated after bedtime and before waking up.
> 1.4 kg wt gain 8AM -10PM with nocturia
Complete a questionnaire. Measure and record weight in AM and PM. Record the number of times and collect all urine passed overnight in separate containers for one week.Collection of blood and interstitial fluid samples, fluorescein dye angiography, and bioimpedance study.

  Show Detailed Description


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with idiopathic edema

Inclusion Criteria:

  • Subjects gaining > 1.4 kg and nocturia

Exclusion Criteria:

  • those not gaining > 1.4 kg and without nocturia
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Please refer to this study by its identifier: NCT01681927

United States, New York
Winthrop-University Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
Winthrop University Hospital
Principal Investigator: John K Maesaka, MD Winthrop University Hospital
  More Information

Responsible Party: John Maesaka, MD, Acting Chief of Nephrology and Hypertension, Winthrop University Hospital Identifier: NCT01681927     History of Changes
Other Study ID Numbers: 220488-4
WUH 350-595 ( Other Identifier: Winthrop-University Hospital )
Study First Received: August 8, 2012
Last Updated: November 2, 2016

Keywords provided by Winthrop University Hospital:
idiopathic edema nocturia

Additional relevant MeSH terms:
Signs and Symptoms
Lower Urinary Tract Symptoms
Urological Manifestations processed this record on April 28, 2017