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The FIBROID Registry

Symptom and Quality-of-Life Status 1 Year After Therapy

From the ¹Department of Radiology, Georgetown University Hospital, Washington, DC; ²Department of Obstetrics and Gynecology and Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina; ³Image Guided Surgery Associates, Philadelphia, Pennsylvania; ⁴Department of Radiological Sciences, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California; and ⁵Department of Radiology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.

OBJECTIVES: To investigate the change in symptom severity and health-related quality of life among patients treated with uterine artery embolization for leiomyomata.

METHODS: Using the Fibroid Registry for Outcomes Data (FIBROID), a multicenter, prospective, voluntary registry of patients undergoing uterine embolization for leiomyomata, we studied changes in symptom status, health-related quality of life, subsequent care, menstrual status, and satisfaction with outcome. Health-related quality-of-life and symptom status were measured using the Uterine Fibroid Symptom and Quality of Life, a leiomyoma-specific questionnaire. Summary statistics were used to describe the data set and multivariate analyses to determine predictors of outcome at 12 months.

RESULTS: Of 2,112 eligible patients, follow-up data were obtained on 1,797 (85.1%) at 6 months and 1,701 (80.5%) at 12 months. At 12 months, the mean symptom score had improved from 58.61 to 19.23 (P < .001), whereas 5.47% of patients had no improvement. The mean health-related quality-of-life score improved from 46.95 to 86.68 (P < .001), whereas 5.0% did not improve.

In the first year after embolization, hysterectomy was performed in 2.9% of patients, with 3.6% requiring gynecologic interventions by 6 months and an additional 5.9% between 6 and 12 months. Amenorrhea as a result of embolization occurred in 7.3% of patients. Of these, 86% were age 45 or older. Most patients were satisfied with their outcome (82% strongly agree or agree). Predictors of a greater symptom change score include smaller leiomyoma size, submucosal location, and presenting symptom of heavy menstrual bleeding.

CONCLUSION: Uterine embolization results in substantial symptom improvement for most patients, with hysterectomy required in only 2.9% of patients in the first 12 months after therapy.

LEVEL OF EVIDENCE: II-3

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