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New medical therapies for fibroids� UPA = oral selective progesterone receptor modulator
� European trials showed that UPA is > placebo and non-inferior to leuprolide in ↓ bleeding and fibroid volume AND has fewer hypoestrogenic symptoms and effects on bone turnover
Obstetrics & Gynecology: November 2018 - Volume 132 -Issue 5 - p 1241-1251
RESULTS• 432 were randomized to one of the 6 treatment arms• 274 (63%) completed study
• Primary Outcome: Rate of and time to amenorrhea in course 1.
• Rates of amenorrhea were 42.0% (97.5% CI 33.3–51.1) and 54.8% (97.5% CI 45.5–63.8) for 5 mg and 10 mg ulipristal, respectively, compared with 0% (97.5% CI 0.0–3.8) for placebo.
• AE: only hot flushes occurred more commonly in UPA groups than placebo groups; no SAEs considered treatment related
� Intermittent treatment with daily doses of 5mg or 10mg ulipristal was > placebo in management of abnormal bleeding in women with symptomatic uterine leiomyomas
� The efficacy of both doses was maintained during the second course of treatment after an off-treatment interval of two menses.
� Reduced leiomyoma volume when data were log- transformed to control for clinical variability
� No evidence for ulipristal-induced liver injury in EU studies, during 6 years of post-marketing experience, rare cases of serious liver injury were reported in patients treated with ulipristal
� Conclusion: “intermittent 12-week courses of treat ment with ulipristal, followed by off-treatment intervals, may be conside red a preferred option for the medical management of symptomatic uterine l eiomyomas, particularly for women desiring uterine-sparing the rapy”
�Objective: To compare long-term health-related quality of life (HRQOL) 1 year after hysterectomy or myomectomy for treatment of uterine fibroids (UFs) and to determine whether route of procedure, race, or age affected improvements in HRQOL
�Design: Prospective cohort study
�Setting: Eight clinical sites throughout the United States
�Patients: A total of 1,113 premenopausal women with UFs who underwent hysterectomy or myomectomy
�Main Outcome Measures: Self-reported HRQOL and Uterine Fibroid Symptom Quality of Life (UF-QOL)
Fibroid Management: What's new?
Results:
�Hysterectomy patients were older with a longer history of symptomatic UF compared with myomectomy patients
�HRQOL improved after both surgeries
�When stratified across race/ethnicity and age, hysterectomy had higher HRQOL scores compared with myomectomy
�There was little difference in HRQOL or symptom severity between abdominal hysterectomy and abdominal myomectomy.
�HRQOL improved in all women 1 year after hysterectomy or myomectomy
�Hysterectomy patients reported higher HRQOL summary scores compared with myomectomy patients however the absence of bleeding after hysterectomy favors the symptom severity score
� When stratified by route, minimally invasive hysterectomy had better HRQOL scores than minimally invasive myomectomy. There was little difference in scores with abdominal approaches.
Fibroid Management: What's new?
Radiofrequency Ablation of Fibroids
Generator with Foot Pedal
3mm RF Handpiece
Laparoscopic Ultrasound
• FDA approved for fibroids November 2012(Acessa™)