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


CONCLUSIONS
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.
Spies
James B
JB
Department of Radiology, Georgetown University Hospital, Washington, DC 20007-2113, USA. spiesj@gunet.georgetown.edu
Myers
Evan R
ER
Worthington-Kirsch
Robert
R
Mulgund
Jyotsna
J
Goodwin
Scott
S
Mauro
Matthew
M
D000328:Adult; D016001:Confidence Intervals; D004621:Embolization, Therapeutic / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007889:Leiomyoma / Q000453:epidemiology / Q000473:pathology* / Q000628:therapy*; D008875:Middle Aged; D015999:Multivariate Analysis; D009657:North Carolina / Q000453:epidemiology; D016017:Odds Ratio; D017060:Patient Satisfaction; D011336:Probability; D011446:Prospective Studies; D011788:Quality of Life; D012042:Registries; D018570:Risk Assessment; D012720:Severity of Illness Index; D018434:Sickness Impact Profile; D013997:Time Factors; D016896:Treatment Outcome; D014594:Uterine Neoplasms / Q000453:epidemiology / Q000473:pathology* / Q000628:therapy*