A multicenter randomized, controlled clinical trial aims to test whether a minimally invasive treatment can relieve chronic pelvic pain and improve the quality of life for women with pelvic venous disease (PeVD). Researchers from Weill Cornell Medicine and the University of North Carolina School of Medicine will lead the study. Having definitive, quantitative evidence of health benefits may increase insurance coverage for the procedure and ensure access for more women.
The condition, caused by faulty pelvic veins around the uterus and ovaries, affects up to 15 percent of women of childbearing age and can have a major impact on daily life. These veins are unable to close or pump blood out of the pelvic area causing blood to pool and create pressure. Though the condition often goes undiagnosed or untreated, a procedure called embolization that reduces blood flow to the enlarged veins in the pelvis and ovaries may offer relief for these women.
We've seen in nonrandomized trials that these minimally invasive procedures reduce the pressure and decrease pelvic pain."
Dr. Ronald Winokur, co-principal investigator, professor of clinical radiology at Weill Cornell Medicine and interventional radiologist at NewYork-Presbyterian/Weill Cornell Medical Center
"We are now going to rigorously test whether women who undergo these procedures experience less pain and pressure and have improved quality of life compared to women who undergo a control procedure." Dr. Gloria Salazar, associate professor of radiology at University of North Carolina Medical School will co-lead the study.
Measuring impact
The EMBOLIZE Study, which is supported by the Society of Interventional Radiology (SIR), VIVA Foundation and Penumbra, Inc. is initially recruiting 40 eligible women with PeVD at five medical centers across the United States. Participants will randomly be assigned to either undergo embolization or a routine diagnostic venography procedure that uses live x-ray imaging to document their conditions.
Women assigned to the embolization procedure will have a thin device threaded through the veins in the neck to the veins in the pelvis. Once at the desired location, a drug can be delivered to pelvic veins and metallic coils or plugs can close off the defective veins. Women assigned to the control group will undergo a similar procedure, where a tube is threaded through the blood vessels to capture images and blood flow in the enlarged veins. Neither group will know which procedure they received. Ultimately, if the procedure is effective and still needed for patients in the control group, they will also receive the treatment.
"To treat the condition, we want to eliminate the vein dilation and pressure to alleviate the pain," explained Dr. Winokur.
Using imaging, surveys and text messages, the study will track changes in pain scores and specific symptoms during pre-treatment and the six months post-treatment, while also assessing physical changes in the body and any reduction in using pain medication.
If the trial demonstrates that the procedure decreases pain, it may help increase awareness of this common but underrecognized condition and encourage more women to seek treatment. Positive results may also provide incentive for insurance companies to cover the relatively expensive procedure.
"If we can show how effective this procedure is, we can change the quality of life for women affected by PeVD for the rest of their lives," he said. "That's a big deal."
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