About six medical centers are comparing the relative cost, benefits, and complications of three minimally invasive techniques used to reduce and eliminate uterine fibroids in women who don’t have cancer and want to preserve their uterus.
Uterine fibroids, which are sometimes referred to as myomas, are muscular tumors that grow in the walls of the uterus. Typically benign, fibroids can grow as a single tumor, or as multiple tumors. Some can be as small as an apple seed, but they can also grow to be as big as a grapefruit. Though they’re typically asymptomatic, fibroids can cause problematic symptoms depending on where they develop and how large they grow. Some women who have such uncommonly problematic fibroids may experience pelvic discomfort, bladder problems, lower back pain, or even abnormal menstrual bleeding so heavy it can lead to the development of anemia. Doctors usually recommend that a patient undergo a hysterectomy, which is the removal of the uterus and the most common surgical procedure to treat uterine fibroids. Although surgery is the only fully curative method, (because without the uterus, fibroids cannot occur), there are other minimally invasive procedures that can eliminate the problematic tumors. The Treatment Results of Uterine Sparing Technologies — or TRUST — Study follows 300 women over a period of five years, and is funded by Halt Medical Inc., the medical device company that developed the Acessa™ Procedure system. This system uses radiofrequency energy to destroy or shrink fibroids so that they no longer cause pain or bleeding, and was approved by the Food and Drug Administration in 2012. In order to find out which of three alternative treatments is best, researchers will compare the procedures’ direct costs, such as hospital stay, procedure costs, complications, safety, and the need for additional therapy. They are also comparing the procedures’ indirect costs, such as recovery rate and time lost from work, as well as quality of life. With the study’s conclusion, patients who want to preserve their uterus will be able to choose the best direction for their treatment, rather than automatically opting for hysterectomy. |