A multicenter, randomized, controlled clinical trial is underway to evaluate the effectiveness of a minimally invasive treatment for chronic pelvic pain in women with pelvic venous disease (PeVD). The EMBOLIZE trial, led by researchers at Weill Cornell Medicine and the University of North Carolina School of Medicine, aims to determine if embolization can alleviate pain and improve the quality of life for women suffering from this condition.
PeVD, caused by faulty pelvic veins around the uterus and ovaries, affects up to 15% of women of childbearing age. These defective veins fail to properly close or pump blood out of the pelvic area, leading to blood pooling and increased pressure. This often undiagnosed and untreated condition can significantly impact daily life.
Trial Design and Methodology
The EMBOLIZE Study (NCT06168058) is supported by the Society of Interventional Radiology (SIR), VIVA Foundation, and Penumbra, Inc. The trial plans to enroll 40 eligible women with PeVD across five medical centers in the United States. Participants will be randomly assigned to either undergo embolization or a routine diagnostic venography procedure.
During the embolization procedure, a thin device is threaded through the veins in the neck to the pelvic veins. Once in position, a drug can be delivered, and metallic coils or plugs are used to close off the defective veins. The control group will undergo a similar procedure involving the threading of a tube through the blood vessels to capture images and assess blood flow in the enlarged veins. Neither group will be aware of which procedure they received. If embolization proves effective and is deemed necessary for patients in the control group, they will also receive the treatment.
Measuring Outcomes and Impact
The study will monitor changes in pain scores and specific symptoms before and for six months after treatment using imaging, surveys, and text messages. Researchers will also assess physical changes and any reduction in pain medication usage.
According to Dr. Ronald Winokur, co-principal investigator and professor of clinical radiology at Weill Cornell Medicine, previous nonrandomized trials have indicated that these minimally invasive procedures can reduce pressure and decrease pelvic pain. "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. Winokur stated.
Dr. Gloria Salazar, associate professor of radiology at the University of North Carolina Medical School, co-leads the study.
Potential Benefits and Future Implications
If the trial demonstrates a significant reduction in pain, it could raise awareness of this underrecognized condition and encourage more women to seek treatment. Furthermore, positive results may incentivize insurance companies to cover the procedure, which is currently relatively expensive.
"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," said Dr. Winokur. "That's a big deal."
