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

The study is a randomized research trial of bilateral ovarian vein embolization (OVE) and pelvic vein embolization (PVE) in women with chronic pelvic pain (CPP), dilated and incompetent ovarian veins ≥6mm and pelvic varices (≥1 veins, >5 mm diameter) to assess for change in pain. Pain will be assessed by visual analog scale (VAS) and other relevant, validated quality of life metrics including the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0 - Pain Intensity, Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 - Global Health, Patient Global Impression of Change (PGIC) and EuroQol five-dimension (EQ 5D). The target population includes women age greater than or equal to 18 years who are pre-menopausal and have symptoms, and clinical and imaging findings corresponding to Pelvic Venous Disease (PeVD). Subjects will be randomized in a 1:1 fashion to embolization (treatment group) or venography only (control group). Follow-up will be assessed weekly and at 1, and 3 months and 6 months post procedure to assess for changes in quality of life in patients who receive ovarian/pelvic vein embolization versus no embolization.

Inclusion criteria

• 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
• Symptoms-Varices-Pathophysiology Classification18 including of one of the following:

•S2V2PBGV,R,NT, S2V2PRGV,R,NT , S2V2PLGV,R,NT, with or without S2V2 PBIIV,R,NT, S2V2 PLIIV,R,NT, S2V2 PRIIV,R,NT

• 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

Exclusion criteria

• 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