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
Weill Medical College of Cornell University
Summary
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.
Description
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, Patie…
Eligibility
- Age range
- 18–75 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion 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: •S2V2PBGV,R,NT, S2V2PRGV,R,NT , S2V2PLGV…
Interventions
- Diagnostic TestTranscatheter Venography
Venographic assessment of ovarian veins and internal iliac veins
- ProcedureBilateral ovarian vein embolization
Intervention will include sclerosis of pelvic varices and coil embolization of the bilateral ovarian veins.
Locations (3)
- Weill Cornell MedicineNew York, New York
- UNC School of MedicineChapel Hill, North Carolina
- Lake Washington VascularBellevue, Washington