The EMBOLIZE trial, a prospective, randomised controlled trial—the first of its kind—was recently launched at the Society of Interventional Radiology (SIR) annual scientific meeting (23–28 March, Salt Lake City, USA), and seeks to investigate the effects of ovarian vein embolization (OVE) and pelvic vein embolization in reducing symptoms in women experiencing chronic pelvic pain due to pelvic venous disease (PeVD).
The trial is a multisociety collaboration between SIR Foundation and The VIVA Foundation, in partnership with Penumbra, and will be led by Ronald S Winokur (Weill Cornell Medicine, New York, USA) and Gloria Salazar (The University of North Carolina, Chapel Hill, USA).
PeVD occurs when enlarged veins develop in the pelvis surrounding the uterus or ovaries, which can lead to severe chronic pelvic pain. Speaking to Interventional News, SIR Foundation chair and member of The VIVA Foundation board of directors Maureen P Kohi (The University of North Carolina, Chapel Hill, USA) referenced a call to action from the World Health Organization (WHO), which looked at global data citing pelvic pain as a central manifestation of the disease in women.
“The main treatment that we’ve been offering is OVE, and we know that the data show a substantial improvement in chronic pain, but we’ve not been able to produce high-quality evidence to support that treatment option. Not only for the scientific community but also to our payers. Many women do not have insurance coverage for this procedure,” said Kohi. In women, these veins can be difficult to see and feel, Neil Mansho Khilnani (Weill Cornell Medicine, New York, USA)—a member of the EMBOLIZE steering committee—explained, which has driven “scepticism” over diagnosing and treating the pain. “The payers also hear this scepticism and jump on that as an opportunity to reduce expenses to their budget.”
The study investigators are seeking women over the age of 18 who have dilated uterine, ovarian or pelvic veins that are causing chronic pain. To determine efficacy, the study will compare changes in the patients’ pain scores on a visual analogue scale from four weeks before treatment through six months post-treatment to evaluate the outcome of vein-directed intervention for venous-origin chronic pelvic pain. Investigators will also evaluate other quality-of-life improvements, improvements in the pelvic vein varices, and changes in pain medication usage.
“Pain is a tricky thing to quantify as there are many variables,” commented Khilnani. “The impact of pain is more important because pain doesn’t just cause pain, it interferes with your life, how many days you’re with your spouse, missing work or how much you are able to do things in your life that are important to you.” To ensure the quality of patient-reported outcomes, the investigators will conduct cognitive interviews to get an accurate “picture” of how pain is affecting the patient.
Salazar is confident that due to the large size of the centres from which the investigators will draw participants, enrolment should begin quickly. “Referral will not be a problem. A problem will be selecting appropriate patients for this study. We have evidence for the role of venous compression in this patient population and so we have specific criteria in terms of evaluating the ovarian minimalisation outcomes,” she said.
The investigators added that, in the setting of challenges in gaining reimbursement for this procedure, the EMBOLIZE trial is actively encouraging providers to refer potential participants who they cannot treat. “It’s in our best interest to broaden the conversation to touch patients who might be looking for treatment as both arms of the study are fully funded,” Khilnani stated, explaining that participants in the untreated arm will eventually receive treatment after six months.
The multi-society partnership with Penumbra is hoped to expand the reach of the trial to give many women in pain the opportunity to participate. “Patients with pelvic venous disease have few treatment options available to them,” said James F Benenati, chief medical officer at Penumbra. “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 pelvic vein embolization to help patients worldwide.”
