Learn more at today's SIR Connect Townhall, 4:45–5:45 p.m. MT.
SIR Foundation, The VIVA Foundation and Penumbra, Inc., announced the launch of the EMBOLIZE Trial, a first-of-its-kind prospective, randomized controlled trial studying the effects of ovarian vein embolization (OVE) and pelvic vein embolization (PVE) in reducing pain in women experiencing chronic pain due to pelvic venous disease (PeVD).
“Women living with chronic pelvic pain often suffer in silence because of a lack of awareness of pelvic venous disease and the minimally invasive treatment options available,” said SIR Foundation Chair Maureen P. Kohi, MD, FSIR, a member of The VIVA Foundation Board of Directors, an interventional radiologist, and chair of the department of radiology at the University of North Carolina Chapel Hill. “This study will solidify the role of OVE in the treatment of women experiencing pain from pelvic venous disease and will also provide evidence needed to ensure insurance coverage for these treatments.”
This trial is a multisociety collaboration between SIR Foundation and The VIVA Foundation, in partnership with Penumbra, Inc. An investigator-initiated clinical trial, EMBOLIZE will be led by Ronald S. Winokur, MD, FSIR, professor of clinical radiology at Weill Cornell Medicine, and Gloria M. Martinez-Salazar, MD, FSIR, associate professor of radiology at the University of North Carolina at Chapel Hill. Both will serve as the national co-principal investigators.
Inside the study
The study investigators are seeking women over the age 18 who have dilated uterine, ovarian vein or pelvic veins that are causing chronic pain. To determine efficacy, the study will compare the effect of bilateral ovarian vein and pelvic vein embolization versus placebo (venography alone) in women with symptoms and signs suggesting venous origin chronic pelvic pain. The study will compare changes in the patients’ pain scores on a visual analog scale from 4 weeks before treatment through 6 months post-treatment. Investigators will also evaluate other quality of life improvements, improvements in the pelvic vein varices, and the changes in pain medication usage. The study will last for 24 months of subject recruitment. The participating women will not be made aware of whether they were treated or just examined with venography to learn the true impact of treatment on their symptoms and the impacts the symptoms have on their lives.
The need for PeVD research
Pelvic venous disorders are treatable conditions. Commonly, PeVD occurs when enlarged veins develop in the pelvis surrounding the uterus or ovaries. This can lead to severe chronic pelvic pain.
One in six women in the United States experiences chronic pelvic pain. Many conditions can cause pelvic pain, including PeVD, which may be the primary pain generator in up to 30% of women with chronic pelvic pain. Many gynecologists and pelvic pain specialists are unaware that PeVD can be the cause of pelvic pain in some patients. As a result, women with PeVD are often misdiagnosed and may receive unnecessary treatment. Because of a lack of high-quality comparative outcomes and evidence demonstrating the benefits of venous interventions to treat PeVD, venous treatments for chronic pelvic pain are often excluded from health insurance policies in the United States, which means PeVD treatments are not always covered.
Treating PeVD
PeVD can be safely and effectively treated when a woman’s doctor consults with a vascular specialist including an interventional radiologist or vascular surgeon. The care team for a woman with PeVD may also include gynecologists, urologists, gastroenterologists, mental health professionals, physical therapists and other specialists, depending on specific symptoms or conditions.
If a venous cause exists, the IR can access the enlarged veins with minimally invasive outpatient procedures and close the abnormal veins to relieve the painful pressure via embolization. After treatment, women can almost immediately return to normal activities.
The EMBOLIZE study will demonstrate the benefits of OVE and PVE in women experiencing chronic pelvic pain of a venous origin and will also provide evidence needed to support referrals by gynecologists as well as improved access to insurance coverage for these treatments.
“Patients with pelvic venous disease have few treatment options available to them,” said James F. Benenati MD, FSIR, chief medical officer at Penumbra, Inc. “Dedicated to advancing innovative therapies that address a significant unmet need, Penumbra’s support of this study will help provide clear evidence of the benefits of OVE and PVE to help patients worldwide.”
