PURPOSE: To determine the long-term outcome of uterine fibroid therapy (UFE) using tris-acryl gelatin microspheres (TAGM). MATERIALS: This was a multicenter prospective study of patients undergoing UFE with TAGM, and during this phase of the study, the clinical outcomes 3 years after treatment were assessed. Measures of outcome included the Ruta Menorrhagia Questionnaire, patient self-assessments of symptoms and impact on activities, patient satisfaction and health-related quality of life as measured by the SF-12. Long-term re-intervention rates were also assessed. The data were analyzed at each interval compared to baseline using appropriate statistical tests. RESULTS: Of the 102 patients enrolled, 96 patients had complete baseline data and of these, 69 (72%) had known outcomes at 3 years after treatment. Sixty-one patients (64%) completed long-term follow-up without major intervention. An additional 8 patients (8.3%) underwent fibroid surgery (7 hysterectomies and 1 myomectomy). Among those without intervention, at 3 years after treatment, the mean Ruta Questionnaire Score was 19.3, compared to 47.9 at baseline and 24.5 at 3 months (P <.01). At baseline, 57% of patients had extremely heavy bleeding, while only 2% had that complaint at 36 months. At 36 months, much or moderate improvement in pelvic pain occurred in 83% of patients, pelvic discomfort in 83%, and urinary problems in 69% and 84% were moderately or very satisfied with their outcome. CONCLUSIONS: Over the long-term, UFE using TAGM is effective and safe, with high levels of durable symptom control, improved health-related quality of life and patient satisfaction.
PURPOSE: To determine the long-term outcome of uterine fibroid therapy (UFE) using tris-acryl gelatin microspheres (TAGM). MATERIALS: This was a multicenter prospective study of patients undergoing UFE with TAGM, and during this phase of the study, the clinical outcomes 3 years after treatment were assessed. Measures of outcome included the Ruta Menorrhagia Questionnaire, patient self-assessments of symptoms and impact on activities, patient satisfaction and health-related quality of life as measured by the SF-12. Long-term re-intervention rates were also assessed. The data were analyzed at each interval compared to baseline using appropriate statistical tests. RESULTS: Of the 102 patients enrolled, 96 patients had complete baseline data and of these, 69 (72%) had known outcomes at 3 years after treatment. Sixty-one patients (64%) completed long-term follow-up without major intervention. An additional 8 patients (8.3%) underwent fibroid surgery (7 hysterectomies and 1 myomectomy). Among those without intervention, at 3 years after treatment, the mean Ruta Questionnaire Score was 19.3, compared to 47.9 at baseline and 24.5 at 3 months (P <.01). At baseline, 57% of patients had extremely heavy bleeding, while only 2% had that complaint at 36 months. At 36 months, much or moderate improvement in pelvic pain occurred in 83% of patients, pelvic discomfort in 83%, and urinary problems in 69% and 84% were moderately or very satisfied with their outcome. CONCLUSIONS: Over the long-term, UFE using TAGM is effective and safe, with high levels of durable symptom control, improved health-related quality of life and patient satisfaction.
Authors: David Shveiky; Cheryl B Iglesia; Danielle D Antosh; Bela I Kudish; Joanna Peterson; Chun-Chih Huang; Chun-Chin Huang; James B Spies Journal: Int Urogynecol J Date: 2012-12-18 Impact factor: 2.894