TABLE 4.

Clinical comparison of ulipristal with surgery, comparing advantages and limitations, also showing literature regarding morbidity and mortality

	Ulipristal acetate	Uterine artery embolization	Myomectomy	Hysterectomy
Advantages	‐ sole available long‐term treatment (up to 4 12 week treatment courses) ‐ sustained effect on fibroid/uterus volume ‐ Favourable side effects ‐ pregnancy not impaired	Noninvasive surgical technique Reduction of symptoms Improvement of QoL	Usually pregnancy after treatment is possible Reduction of symptoms Improvement of QoL	Reduction of symptoms No fibroid complaints No menstrual bleeding Improvement of QoL Definite treatment option
Limitations	‐ frequent LFT ‐ literature shows fibroid reducing effect, in population with relatively small uterine fibroids ‐ chance on symptom‐recurrence after cessation of therapy	‐ risk for premature ovarian failure ‐ unknown effect on fertility, pregnancy after treatment is discouraged ‐ risk for procedure‐related complications ‐ risk for re‐intervention	‐ risk for subfertility ‐ risk for procedure‐related complications	Fertility impaired after treatment Risk for procedure‐related complications Altman et al.61: Increased risk for subsequent stress urinary incontinence (SUI) (HR 2.4; 95% CI 2.3–3.5) Overall surgical intervention rate due to SUI is more than doubled for women who had a hysterectomy
Mild morbidity	‐ reversible endometrial changes ‐ possible chance for mild/moderate DILI	‐ 1:33–1:20 re‐intervention ‐ 35% chance on secondary hysterectomy65, 66, 67, 68 ‐ 24% occurrence of perioperative and postdischarge complications71	‐ 29% occurrence of perioperative and postdischarge complications71	Cochrane Review57 1: 63 urinary tract injury (vaginal approach) 1: 42 urinary tract injury (laparoscopic approach)
Severe morbidity	1.5: 100 000 for severe DILI	Manyonda et al.71: ‐ 1:50 chance on major haemorrhage perioperative and predischarge 14% chance on postdischarge infection	Manyonda et al.71: 1:20 chance on major haemorrhage perioperative and predischarge ‐ 17% chance on postdischarge infection 1:25 chance on general complications78: ‐ intraoperative haemorrhage requiring blood transfusion ‐ emergency hysterectomy	Cochrane Review57 1:100 for haemorrhage, vesicoperitoneal fistula, ureteral injury, rectal perforation or fistula USA case series 1998–2010 (n = 664 229): 1:56–1:46 for haemorrhage 1:40–1:23 for respiratory failure 1:67–1:40 for infections German analysis ‘12 (n = 103 232)63: 1:100–1:25 for intra‐ and postoperative complication rates France survey 2006–2015 (n = 109 884)64: 1:13 severe complications in 60 months follow up
Mortality	0.1: 100 000 for fatal DILI	Death is reported in cases due to e.g. infection or pulmonary embolism69, 70		USA case series 1998–2010 (n = 664 229): 1:588 (abdominal approach) German analysis 2012 (n = 103 232)63: 1:3700

QoL: quality of life; LFT: liver function test; SUI: stress urinary incontinence; HR: hazard ratio; CI: confidence interval; DILI: drug‐induced liver injury