Minimally Invasive Treatment for Pelvic Venous Disease: Clinical Trial
Minimally Invasive Treatment Offers hope for Women Suffering from Chronic Pelvic Pain
New York, NY - A groundbreaking clinical trial is underway to determine the effectiveness of a minimally invasive procedure in relieving chronic pelvic pain for millions of women suffering from pelvic venous disease (PeVD). Led by researchers from Weill Cornell Medicine and the University of North Carolina School of Medicine, the EMBOLIZE Study aims to provide definitive evidence of the procedure’s benefits, potentially leading to increased insurance coverage and improved access to care.
PeVD, a condition affecting up to 15% of women of childbearing age, occurs when veins around the uterus and ovaries malfunction, causing blood to pool and create pressure. This can lead to debilitating chronic pelvic pain, considerably impacting daily life. While often undiagnosed or untreated, a procedure called embolization offers a potential solution.
“We’ve seen in non-randomized trials that these minimally invasive procedures reduce the pressure and decrease pelvic pain,” says Dr. Ronald Winokur, co-principal investigator and professor of clinical radiology at Weill Cornell Medicine.”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.”
The EMBOLIZE Study, supported by the Society of Interventional Radiology (SIR), VIVA Foundation, and Penumbra, Inc., is currently recruiting 40 eligible women at five medical centers across the United States. Participants will be randomly assigned to either undergo embolization or a diagnostic venography procedure.
during embolization, a thin device is threaded through veins in the neck to the pelvis. Onc in place, a drug can be delivered to the affected veins, and metallic coils or plugs are used to close them off, effectively eliminating the source of pain. The control group will undergo a similar procedure to capture images and assess blood flow, but without the embolization treatment.
“To treat the condition, we want to eliminate the vein dilation and pressure to alleviate the pain,” explains Dr. Winokur.
Researchers will closely monitor participants for six months post-treatment, tracking changes in pain scores, symptoms, physical changes, and medication use through imaging, surveys, and text messages.
If the trial proves successful, it could have a profound impact on the lives of countless women. Positive results could raise awareness of PeVD, encourage more women to seek treatment, and incentivize insurance companies to cover the 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,” says Dr. Winokur. “That’s a big deal.”
Minimally Invasive Treatment Offers Hope for Women Suffering from Chronic Pelvic Pain
New York, NY – A groundbreaking clinical trial is underway to determine the effectiveness of a minimally invasive procedure in relieving chronic pelvic pain for millions of women suffering from pelvic venous disease (PeVD). Led by researchers from Weill Cornell Medicine and the University of North Carolina School of Medicine, the EMBOLIZE Study aims to provide definitive evidence of the procedure’s benefits, potentially leading to increased insurance coverage and improved access to care.
PeVD, a condition affecting up to 15% of women of childbearing age, occurs when veins around the uterus and ovaries malfunction, causing blood to pool and create pressure. This can lead to debilitating chronic pelvic pain, considerably impacting daily life. While often undiagnosed or untreated, a procedure called embolization offers a potential solution.
“We’ve seen in non-randomized trials that these minimally invasive procedures reduce the pressure and decrease pelvic pain,” says Dr. Ronald Winokur, co-principal investigator and professor of clinical radiology at Weill Cornell Medicine.”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.”
The EMBOLIZE Study, supported by the Society of Interventional Radiology (SIR), VIVA Foundation, and Penumbra, inc., is currently recruiting 40 eligible women at five medical centers across the United States.Participants will be randomly assigned to either undergo embolization or a diagnostic venography procedure.
During embolization, a thin device is threaded through veins in the neck to the pelvis. once in place, a drug can be delivered to the affected veins, and metallic coils or plugs are used to close them off, effectively eliminating the source of pain. The control group will undergo a similar procedure to capture images and assess blood flow, but without the embolization treatment.
“To treat the condition, we want to eliminate the vein dilation and pressure to alleviate the pain,” explains Dr. Winokur.
Researchers will closely monitor participants for six months post-treatment, tracking changes in pain scores, symptoms, physical changes, and medication use through imaging, surveys, and text messages.
If the trial proves prosperous, it could have a profound impact on the lives of countless women. Positive results could raise awareness of PeVD, encourage more women to seek treatment, and incentivize insurance companies to cover the 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,” says Dr. winokur.”That’s a big deal.”