Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices

Eligibility Criteria

• 1. Presence of venous origin chronic pelvic pain for greater than 6 months (VAS ≥7 as determined by 4 consecutive weeks of baseline self-assessments) despite non-vascular therapy as delineated by the following criteria:
• * 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
• 2. Symptoms-Varices-Pathophysiology Classification18 including of one of the following:
• 3. CT, TAUS and diagnostic venography (if needed) imaging review for pelvic venous imaging factors
• * Left or right ovarian vein diameter greater than or equal to 6 mm as documented by TAUS or CT
• * Presence of intrabdominal/pelvic varices as documented by TAUS or CT (≥1 veins, \>5 mm diameter)
• * Presence of venous reflux in ovarian and/or internal iliac veins without evidence of hemodynamically significant stenosis
• * 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
• * Patient who is post-menopausal or anovulatory with hormone suppression
• * History of prior hysterectomy
• * Prior ovarian vein embolization or ovarian vein ligation
• * Inability to tolerate endovascular procedure due to acute illness or general health
• * Planned simultaneous treatment with nerve blocks during the duration of the study
• * Laparoscopy or planned surgical intervention during the duration of the study
• * Known allergy to sclerosant, coil, stent or catheter components including nickel allergy
• * Any iliac vein stenosis determined identified by the investigator on pelvic DUS, CT venogram, and/or Catheter Venography and deemed significant for exclusion by study patient review committee.
• * Any renal vein stenosis with resultant renal hilar varices/collaterals and lumbar collaterals identified by the investigator on pelvic DUS, CT venogram, and/or Diagnostic Venography and deemed significant for exclusion by study patient review committee.
• * Presence of isolated extra-pelvic vulvar and/or lower extremity varices without intrabdominal pelvic varices. Primary S3 categorization study exclusion.
• * Serious medical conditions that might preclude full participation in the study to the desired endpoint (e.g., uncontrolled diabetes, malignancy, COPD, MI, CHF, etc.)
• * Severe allergy to iodinated or gadolinium-based contrast refractory to steroid premedication
• * Severe renal impairment (on chronic dialysis or estimated GFR \<30 mL/min)
• * Hemoglobin \<8.0 g/dL, uncorrectable INR \>3.0 or platelet count \<75,000/microliter
• * Inability to provide informed consent or to comply with study assessments
• * Post thrombotic IVC, iliac or ovarian vein changes