The FIBROID Registry: symptom and quality-of-life status 1 year after therapy

Obstet Gynecol. 2005 Dec;106(6):1309-18. doi: 10.1097/01.AOG.0000188386.53878.49.

Abstract

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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Confidence Intervals
  • Embolization, Therapeutic / adverse effects
  • Embolization, Therapeutic / methods*
  • Female
  • Follow-Up Studies
  • Humans
  • Leiomyoma / epidemiology
  • Leiomyoma / pathology*
  • Leiomyoma / therapy*
  • Middle Aged
  • Multivariate Analysis
  • North Carolina / epidemiology
  • Odds Ratio
  • Patient Satisfaction
  • Probability
  • Prospective Studies
  • Quality of Life*
  • Registries
  • Risk Assessment
  • Severity of Illness Index
  • Sickness Impact Profile
  • Time Factors
  • Treatment Outcome
  • Uterine Neoplasms / epidemiology
  • Uterine Neoplasms / pathology*
  • Uterine Neoplasms / therapy*