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 of women with pelvic vein 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 can 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 significant impact on daily life. These veins cannot close or pump blood from the pelvic area causing blood to pool and build up pressure. Although the condition often goes undiagnosed or untreated, a procedure called embolization that reduces blood flow to enlarged veins in the pelvis and ovaries can provide relief for these women.
We have seen in non-randomized trials that these minimally invasive procedures reduce pressure and reduce 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 an improved quality of life compared to women who undergo a control procedure.” Dr. Gloria Salazar, associate professor of radiology at the University of North Carolina School of Medicine will co-supervise the study.
Measuring impact
The EMBOLIZE study, which is supported by the Society for Interventional Radiology (SIR), the VIVA Foundation and Penumbra, Inc. is initially recruiting 40 eligible women with PeVD at five medical centers in the United States. Participants will be randomly assigned to either undergo an embolization or a routine diagnostic venography procedure that uses live X-rays to document their condition.
Women who are assigned the embolization procedure will have a thin device passed through the veins in the neck to the veins in the pelvis. Once in the desired location, a drug can be administered into the pelvic veins, and metal coils or plugs can close off the defective veins. Women assigned to the control group will undergo a similar procedure, where a tube is passed through the blood vessels to capture images and blood flow in the enlarged veins. Neither team will know which process they received. Ultimately, if the procedure is effective and is still required for patients in the control group, they will also receive the treatment.
“To treat the condition, we want to eliminate vein dilation and pressure to relieve pain,” explained Dr. Winokur.
Using imaging, surveys and text messages, the study will monitor changes in pain scores and specific symptoms at pre-treatment and six months after treatment, while also assessing physical changes in the body and any reduction in pain medication use.
If the trial shows that the procedure reduces pain, it may help raise awareness of this common but under-recognized condition and encourage more women to seek treatment. Positive results may also provide an 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 of women affected by PeVD for the rest of their lives,” he said. “This is a big deal.”
