Randomized Controlled, Single-Blinded, Parallel-Group Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices (EMBOLIZE) Trial
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.
• 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