Trial Information

Outcome From Fibroid Therapies: A Comparison With Normal Controls

Uterine fibroids are the most common benign uterine tumor affecting approximately 70% of all
women in the United States. Sixty percent of the 600,000 hysterectomies performed in the
United States annually are done because of uterine fibroids. Hysterectomy has been the
definitive treatment for fibroids and has been demonstrated to be effective in controlling
symptoms. However, there have been few studies comparing the outcome of hysterectomy to
other surgical and non-surgical therapies or to the outcomes experienced by a "normal"
population, i.e. those not diagnosed with fibroids. Similarly, the relative effectiveness
of myomectomy and uterine fibroid embolization has not been evaluated in the context of
other fibroid therapies and minimally invasive variations. Fibroid symptoms experienced by
patients are subjective and have not been shown to correlate with fibroid number, size,
location, or any other clinical measure of fibroids. As symptoms and their impact are the
primary outcomes experienced by patients, a validated questionnaire to measure this impact
is needed.

The Uterine Fibroid Symptom and Quality of Life Questionnaire (UFS-QoL) was developed from
focus groups of women with leiomyomata. The original items captured key symptoms and areas
of life impact voiced by the focus group participants. Content validity was established
through cognitive debriefings of women with leiomyomata and review by expert clinicians.
The UFS-QoL was then validated in a patient population of women with leiomyomata as well as
"normal" controls.

Using the UFS-Qol as the primary measure, this study will provide the basis of comparison
for women with uterine fibroids both before and after therapy. "Normal" scores will be
established from patients without fibroids. These data will provide the basis for comparing
these outcomes to those resulting from a variety of investigational therapies. It will also
provide insight into the progression of fibroid-related symptoms in patients established as
normal at baseline.

The objectives of this study are:

A. To determine the change in symptoms and health-related quality of life in patients
undergoing hysterectomy, myomectomy, and uterine fibroid embolization.

B. To compare the outcomes of each intervention with a normal control group as well as with
the other therapies.

C. To validate the UFS-QoL questionnaire in a normal population to determine a normal score
range.

D. To validate the UFS-QoL questionnaire in hysterectomy patients to determine a "normal"
score for patients without a uterus.