The FIBROID registry - Symptom and quality-of-life status 1 year after therapy

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.