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Outcome From Fibroid Therapies: A Comparison With Normal Controls


N/A
35 Years
50 Years
Open (Enrolling)
Female
Leiomyoma

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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.


Inclusion Criteria:

Fibroid Treatment Group

- Pre-menopausal

- Between the ages of 35 and 50, inclusive

- Scheduled to undergo hysterectomy, myomectomy, or uterine fibroid embolization for
treatment of uterine fibroids at one of the participating institutions

- Willing to provide written informed consent

- Able to speak and read English

Inclusion Criteria:

Normal Control Group (patients not diagnosed with fibroids)

- Pre-menopausal

- Between the ages of 35 and 50, inclusive

- Normal gynecologic examination at time of enrollment with regular menstrual cycle at
the time of enrollment

- Willing to provide written informed consent

- Able to read and speak English

Exclusion Criteria: Fibroid Treatment Group

- Currently pregnant

- Cognitive impairment that would interfere with completing the questionnaire

- Severe psychiatric co-morbidity

- Co-morbid or life-threatening condition with life expectancy to be less than 1 year

- Active duty military healthcare beneficiary

Exclusion Criteria: Normal Control Group

- Currently pregnant

- Presence of other gynecologic-related diseases (e.g. endometriosis, pelvic
inflammatory disease)

- Cognitive impairment that would interfere with completing the questionnaire

- Severe psychiatric co-morbidity

- Co-morbid or life-threatening condition with life expectancy to be less than 1 year

- Active duty military healthcare beneficiary

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

James B Spies, MD

Investigator Role:

Study Director

Investigator Affiliation:

Georgetown University Hospital

Authority:

United States: Federal Government

Study ID:

04-44020

NCT ID:

NCT00390494

Start Date:

December 2005

Completion Date:

December 2010

Related Keywords:

  • Leiomyoma
  • Fibroids
  • Leiomyoma
  • Hysterectomy
  • Myomectomy
  • Uterine Fibroid Embolization
  • Questionnaire
  • Leiomyoma
  • Myofibroma

Name

Location

Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
The Cleveland Clinic FoundationCleveland, Ohio  
Georgetown University HospitalWashington, District of Columbia  20007