Penn doing fibroid study
They’re examining overall effectiveness of different agents used to destroy uterine fibroids - a discovery that could lead to more answers about the durability of a procedure called Uterine Fibroid Embolization (UFE). It’s been established in the medical community that, after a decade, UFE works to relieve the symptoms of fibroids. In this study, investigators want to learn how to optimize the procedure by running a comparison of materials used during it.
“We already know UFE has an 85-90% success rate, offering fewer complications and a shorter recovery time than surgical options,” Dr. Richard Shlansky-Goldberg, interventional radiologist at Penn and lead investigator of this study, explained. “The question becomes, now that we know the procedure is effective and durable, ‘Which product would be better’?”
Uterine fibroids are non-cancerous tumors of the uterus that affect an estimated 20-40% of women, and for many cause symptoms disrupting the quality of their lives. Uterine fibroids affect more than six million women in the
The treatment depends upon the size and location of the fibroids and the severity of symptoms. UFE, also known as uterine artery embolization (UAE), is a minimally-invasive alternative to a hysterectomy and is a proven way to treat fibroids and relieve its symptoms of heavy bleeding, pressure, pain, and excessive urination.
Interventional radiologists don’t actually remove the fibroids during the UFE procedure. They shut them down and gradually shrink them, by blocking the blood supply to the fibroids. They do this by using a catheter to inject embolic agents (tiny plastic or sponge-like particles) into the artery, to “dam up” the blood flow to the fibroids.
During this Penn trial, researchers will utilize two different embolic agents, comparing the outcomes in patients: 24 hours after each procedure, they will conduct an
Dr. Shlansky-Goldberg adds, “We hope to answer two questions. One: In looking at the different outcomes of each particle, does one do a more effective job of eliminating fibroids? Two: What does the uterus look like immediately after the UFE procedure and then after three months?”
This is a randomized, single-center study comparing Contour SE Microspheres to Embosphere Microspheres for treating symptomatic uterine fibroids with UFE. The Penn study, funded by Boston Scientific, will involve 60 patients. Penn is still enrolling patients in the study, and the clinical trial is expected to last about nine months.