(Philadelphia, PA) - Researchers at the University
of Pennsylvania School of Medicine are working on ways
to improve the results of a non-surgical method to treat fibroids.
They are examining the 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 already been established
throughout the medical community that, after a decade, UFE works
to relieve the symptoms of fibroids. Now, in this new study, investigators
want to learn how to optimize the procedure, by running a comparison
of materials used during it.
“We already know that UFE has an 85-90% success rate, offering
less complications and a shorter recovery time than surgical options,”
Richard Shlansky-Goldberg, MD, Interventional Radiologist
at Penn and Principal Investigator of this study, explains, “So
in 2006, the question becomes, now that we know the procedure is
effective and durable, ‘Which product would be better?’”
Uterine fibroids are benign (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 U.S. each year. The exact reason uterine
fibroids (the most common type of abnormal growth in the uterus)
develop is unknown, but medical researchers have associated the
condition with genetics and hormones. If left untreated, uterine
fibroids can cause infertility.
treatment for uterine fibroids depends upon the size and location
of the fibroids and the severity of symptoms. Uterine fibroid embolization
(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 trial at Penn, several researchers will utilize two
different embolic agents, comparing the outcomes in patients. 24
hours after each procedure, they will conduct an MRI to see how
much fibroid tissue is destroyed. They’ll look again, when
the patient leaves the hospital. 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? And two -- What does the uterus look like immediately
after the UFE procedure and then later, after three months?”
This is a randomized, single-center study comparing Contour SE™
Microspheres (manufactured by Boston Scientific Corporation) to
Embosphere® Microspheres (manufactured by BioSphere Medical,
Inc.) for treating symptomatic uterine fibroids with UFE. The head-to-head
study at Penn, funded by Boston Scientific, will involve 60 patients.
Penn is still enrolling patients in the study.
The clinical trial is expected to last about nine months. Penn
Interventional Radiology is a large interventional radiology practice,
with eleven board-certified interventional radiology physicians
Editor’s Note: Dr. Richard Shlansky-Golberg
has no financial interest in Boston Scientific Corporation or BioSphere
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