The purpose of this study is to see if a randomized controlled trial of ovarian vein and pelvic vein embolization versus venography alone could determine outcomes for women with chronic pelvic pain and pelvic varicose veins.
The data gathered will assist in addressing changes in quality of life in patients who have ovarian/pelvic vein embolization versus no embolization.
Pain exacerbated by walking, standing or lifting
Symptoms are at least partially alleviated by lying down
Prolonged post-coital ache
Absence of non-venous origin CPP as determined by Gynecology examination
Female <18 years of age
Pregnancy (positive pregnancy test)
Female subject who plans to become pregnant during study period
Female subject who is actively breastfeeding
Parallel
Transcatheter Venography
Diagnostic testVenographic assessment of ovarian veins and internal iliac veins
Bilateral ovarian vein embolization
Procedure/SurgeryIntervention will include sclerosis of pelvic varices and coil embolization of the bilateral ovarian veins.
Change in Visual Analog Scale (VAS) for pelvic pain
The VAS pain score is a standard scale from 0 to 10, defining 0 as ''no pain'' and 10 ''worst pain possible.''
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 3A Pain Intensity Scale
The Patient-Reported Outcomes Measurement Information System (PROMIS) 3A Pain Intensity Scale assess how much a person hurts. The scale ranges from 1-5, defining 1 as ''no pain'' and 5 ''very severe pain.''
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Pain Intensity Scale
The Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health measures assess an individual's physical, mental, and social health. The scale scores from from 5 to 1 with 5 = "Excellent" and 1= "Poor ".
Change in Patient Global Impression of Change (PGIC)
The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale with 1= "Very Much Improved" and 7= "Very Much Worse".
Change in EuroQol five-dimension (EQ-5D) scale
The EuroQol five-dimension (EQ-5D) is a concise, generic measure of self-reported health at each visit. Patients will tick the one box that best describes their health on that day. This scale will measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.The scale is numbered from 0 to 100. =100 means the best health the patient can imagine and 0 means the worst health the patient can imagine,.
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Weill Medical College of Cornell University
Lead sponsor
Society of Interventional Radiology Foundation
Collaborator
VIVA Physicians
Collaborator
Penumbra Inc.
Collaborator
