| 1. Ascher SM, Wasnik AP, Robbins JB, et al. ACR Appropriateness Criteria® Fibroids. J Am Coll Radiol 2022;19:S319-S28. |
Review/Other-Dx |
N/A |
Evidence-based guidelines to assist referring physicians and other providers in making the most appropriate imaging or treatment decision for fribroids. |
No results stated in abstract. |
4 |
| 2. Kohn JR, Shamshirsaz AA, Popek E, Guan X, Belfort MA, Fox KA. Pregnancy after endometrial ablation: a systematic review. BJOG 2018;125:43-53. |
Meta-analysis |
99 studies |
To review systematically the available evidence regarding pregnancy outcomes after endometrial ablation, in order to equip physicians effectively to counsel women considering endometrial ablation. |
We identified 274 pregnancies from 99 sources; 78 sources were case reports. Women aged 26-50 years (mean 37.5 ± 5 years) conceived a median of 1.5 years after ablation (range: 3 weeks prior to 13 years after). When reported, 80-90% had not used contraception. In all, 85% of pregnancies from trial/observational studies ended in termination, miscarriage or ectopic pregnancy. Pregnancies that continued (case report and non-case report sources) had high rates of preterm delivery, caesarean delivery, caesarean hysterectomy, and morbidly adherent placenta. Case reports also frequently described preterm premature rupture of membranes, intrauterine growth restriction, intrauterine fetal demise, uterine rupture, and neonatal demise. |
Inadequate |
| 3. Kim T, Purdy MP, Kendall-Rauchfuss L, et al. Myomectomy associated blood transfusion risk and morbidity after surgery. Fertil Steril. 114(1):175-184, 2020 07. |
Observational-Tx |
3,407 myomectomies overall (416 hysteroscopic, 1,292 laparoscopic, and 1,699 open/abdominal myomectomies) |
To evaluate blood transfusion risks and the associated 30-day postoperative morbidity after myomectomy. |
The overall rate of blood transfusion was 10% (hysteroscopy, 6.7%; laparoscopy, 2.7%; open/abdominal procedures, 16.4%). Independent risk factors for transfusion included as follows: black race (adjusted odds ratio [aOR] 2.27, 95% confidence interval [CI] 1.62-3.17) and other race (aOR 1.77, 95% CI 1.20-2.63) compared with white race; preoperative hematocrit <30% compared to =30% (aOR 6.41, 95% CI 4.45-9.23); preoperative blood transfusion (aOR 2.81, 95% CI 1.46-5.40); high fibroid burden (aOR 1.91, 95% CI 1.45-2.51); prolonged surgical time (fourth quartile vs. first quartile aOR 11.55, 95% CI 7.05-18.93); and open/abdominal approach (open/abdominal vs. laparoscopic aOR 9.06, 95% CI 6.10-13.47). Even after adjusting for confounders, women who required blood transfusions had an approximately threefold increased risk for experiencing a major postoperative complication (aOR 2.69, 95% CI 1.58-4.57). |
3 |
| 4. Laughlin-Tommaso SK, Lu D, Thomas L, et al. Short-term quality of life after myomectomy for uterine fibroids from the COMPARE-UF Fibroid Registry. Am J Obstet Gynecol. 222(4):345.e1-345.e22, 2020 04. |
Observational-Tx |
1206 women from 8 COMPARE-UF sites underwent myomectomy (338 hysteroscopic, 519 laparoscopic, and 349 abdominal) |
To compare women's perception of their short-term health-related quality of life measures and reported time to return to usual activities and return to work for different routes of myomectomy. |
A total of 1206 women from 8 COMPARE-UF sites underwent myomectomy (338 hysteroscopic, 519 laparoscopic, and 349 abdominal). All women had substantial improvement in short-term health-related quality of life and symptom severity scores, which was not different among groups. Average symptom severity scores decreased about 30 points in each group. Return to usual activities averaged 0 days (interquartile range, 0-14 days) for hysteroscopic myomectomy, 21 days (interquartile range, 14-28 days) for laparoscopic myomectomy, and 28 days (interquartile range, 14-35 days) for abdominal myomectomy. After propensity adjustment, quality of life outcomes in the laparoscopic and abdominal myomectomy groups were similar except for more anxiety in the laparoscopic myomectomy group and slightly more pain in the abdominal myomectomy group. After propensity weighting, return to usual activities favored laparoscopic compared to abdominal procedures; median time was the same at 21 days, but the highest quartile of women in the abdominal group needed an additional week of recovery (interquartile range,14.0-28.0 for laparoscopic versus 14.0-35.0 for abdominal, P < .01). Time to return to work was also longer in the abdominal arm (median, 22 days; interquartile range, 14-40 days, versus median, 42; interquartile range, 27-56). |
2 |
| 5. Daniels J, Middleton LJ, Cheed V, et al. Uterine artery embolization or myomectomy for women with uterine fibroids: Four-year follow-up of a randomised controlled trial. Eur J Obstet Gynecol Reprod Biol X 2022;13:100139. |
Experimental-Tx |
254 women were randomized, 127 to myomectomy (105 underwent myomectomy) and 127 to uterine artery embolization (98 underwent embolization) |
To examine the quality of life experienced by women with symptomatic uterine fibroids who had been treated with UAE in comparison to myomectomy |
At four years, 67 (53%) and 81 (64%) completed UFS-QoL quality of life scores. Mean difference in the UFS-QoL at 4 years was 5.0 points (95% CI -1.4 to 11.5; p = 0.13) in favour of myomectomy. There were 15 pregnancies in the UAE group and 7 in the myomectomy group, with a cumulative pregnancy rate to four years of 15% and 6% respectively (hazard ratio: 0.48; 95% CI 0.18-1.28). The cumulative repeat procedure rate to four years was 24% in the UAE group and 13% in the myomectomy group (hazard ratio: 0.53; 95% CI 0.27-1.05). |
1 |
| 6. Manyonda I, Belli AM, Lumsden MA, et al. Uterine-Artery Embolization or Myomectomy for Uterine Fibroids. N Engl J Med. 383(5):440-451, 2020 07 30. |
Observational-Tx |
254 women |
To evaluate myomectomy, as compared with uterine-artery embolization, in women who had symptomatic uterine fibroids and did not want to undergo hysterectomy. |
Data on the primary outcome were available for 206 women (81%). In the intention-to-treat analysis, the mean (+/-SD) score on the health-related quality-of-life domain of the UFS-QOL questionnaire at 2 years was 84.6+/-21.5 in the myomectomy group and 80.0+/-22.0 in the uterine-artery embolization group (mean adjusted difference with complete case analysis, 8.0 points; 95% confidence interval [CI], 1.8 to 14.1; P = 0.01; mean adjusted difference with missing responses imputed, 6.5 points; 95% CI, 1.1 to 11.9). Perioperative and postoperative complications from all initial procedures, irrespective of adherence to the assigned procedure, occurred in 29% of the women in the myomectomy group and in 24% of the women in the uterine-artery embolization group. |
4 |
| 7. Casini ML, Rossi F, Agostini R, Unfer V. Effects of the position of fibroids on fertility. Gynecol Endocrinol 2006;22:106-9. |
Experimental-Tx |
181 women affected by uterine fibroids who had been trying to conceive for at least 1 year without success |
To evaluate whether the location of uterine fibroids may influence reproductive function in women and whether removal of the fibroid prior to conception may improve pregnancy rate and pregnancy maintenance. |
Among the patients who underwent myomectomy, the pregnancy rates obtained were 43.3% in cases of submucosal, 56.5% in cases of intramural, 40.0% in cases of submucosal-intramural and 35.5% in cases of intramural-subserosal uterine fibroids, respectively. Among the patients who did not undergo surgical treatment, the pregnancy rates obtained were 27.2% in women with submucosal, 41.0% in women with intramural, 15.0% in women with submucosal-intramural and 21.43% in women with intramural-subserosal uterine fibroids, respectively. |
1 |
| 8. Jayaprakasan K, Polanski L, Sahu B, Thornton JG, Raine-Fenning N. Surgical intervention versus expectant management for endometrial polyps in subfertile women. The Cochrane database of systematic reviews 2014;2014:CD009592. |
Review/Other-Tx |
1 RCT |
To determine the eHectiveness and safety of removal of endometrial polyps in subfertile women. |
Only one randomised controlled trial of endometrial polypectomy was identified for inclusion. However, a single set of data could not be extracted from this study due to internal inconsistencies of the results reported. Attempts to contact the authors to resolve the issue were unsuccessful, by phone, post and e-mail. |
4 |
| 9. Perez-Medina T, Bajo-Arenas J, Salazar F, et al. Endometrial polyps and their implication in the pregnancy rates of patients undergoing intrauterine insemination: a prospective, randomized study. Hum Reprod 2005;20:1632-5. |
Observational-Tx |
101 patients in study group, 103 patients in control group |
To determine whether hysteroscopic polypectomy before intrauterine insemination (IUI) achieved better pregnancy outcomes than no intervention. |
Total pregnancy rates and time for success in both groups after four IUI cycles were compared by means of contingency tables and life-table analysis. A total of 93 pregnancies occurred, 64 in the study group and 29 in the control group. Women in the study group had a better possibility of becoming pregnant after polypectomy, with a relative risk of 2.1 (95% confidence interval 1.5-2.9). Pregnancies in the study group were obtained before the first IUI in 65% of cases. |
1 |
| 10. Litta P, Conte L, De Marchi F, Saccardi C, Angioni S. Pregnancy outcome after hysteroscopic myomectomy. Gynecol Endocrinol 2014;30:149-52. |
Observational-Tx |
104 women with at least a 1-year-long history of infertility and the presence of submucosal myomas |
To evaluate the influence of submucosal myomas on pregnancy outcome in infertile patients after resectoscopic myomectomy. |
Patients were divided into three groups according to the myoma classification (G0, G1 and G2). Gestational outcomes were analyzed in the three groups correlated by size, location and number of fibroids. The total pregnancy rate was 85.8% and no difference was shown regarding myoma classification (G0 82.05% versus G1 87.09% versus G2 88.2%; p = ns). Pregnancy and delivery rates were not significantly related to the number, localization or diameter of the fibroids. The abortion rate was not statistically influenced by myoma type, but it was significantly inter-related with myomas situated in the anterior uterine wall (p = 0.03). Pre-term delivery was significantly influenced by myomas localized in the fundic wall (p = 0.02). |
2 |
| 11. Wise LA, Thomas L, Anderson S, et al. Route of myomectomy and fertility: a prospective cohort study. Fertil Steril 2022;117:1083-93. |
Observational-Tx |
1,095 women who underwent myomectomy (abdominal = 388, hysteroscopic = 273, and laparoscopic = 434) |
To assess prospectively the association between the myomectomy route and fertility. |
Among 1,095 women who underwent myomectomy (abdominal = 388, hysteroscopic = 273, and laparoscopic = 434), 202 reported pregnancy and 91 reported live birth during 36 months of follow-up. There was little difference in the 12-month probability of pregnancy or live birth by route of myomectomy overall or among women intending pregnancy. In interval-based analyses, adjusted ORs for pregnancy were 1.28 (95% CI, 0.76-2.14) for hysteroscopic myomectomy and 1.19 (95% CI, 0.76-1.85) for laparoscopic myomectomy compared with abdominal myomectomy. Among women intending pregnancy, adjusted ORs were 1.27 (95% CI, 0.72-2.23) for hysteroscopic myomectomy and 1.26 (95% CI, 0.77-2.04) for laparoscopic myomectomy compared with abdominal myomectomy. Associations were slightly stronger but less precise for live birth. |
2 |
| 12. Chen R, Su Z, Yang L, Xin L, Yuan X, Wang Y. The effects and costs of laparoscopic versus abdominal myomectomy in patients with uterine fibroids: a systematic review and meta-analysis. BMC surg.. 20(1):55, 2020 Mar 20. |
Meta-analysis |
12 RCTs (1783 patients) |
To analyze the role of laparoscopic myomectomy (LM) versus abdominal myomectomy (AM) in patients with uterine fibroids. |
Twelve RCTs with a total of 1783 patients were identified, with 887 patients for and 897 patients for AM. Compared with AM, LM could significantly decrease the blood loss (OR = - 29.78, 95% CI -57.62- - 0.95), shorten the duration of postoperative ileus (OR = - 10.91, 95% CI -18.72- - 3.11), reduce the length of hospital stay (OR = - 1.57, 95% CI -2.05- - 1.08), but LM was associated with longer duration of operation (OR = 16.10, 95% CI 6.52-25.67) and higher medical cost (OR = 17.61, 95% CI 7.34-27.88). |
Good |
| 13. de Bruijn AM, Ankum WM, Reekers JA, et al. Uterine artery embolization vs hysterectomy in the treatment of symptomatic uterine fibroids: 10-year outcomes from the randomized EMMY trial. Am J Obstet Gynecol. 215(6):745.e1-745.e12, 2016 Dec. |
Experimental-Tx |
81 uterine artery embolization patients and 75 hysterectomy patients |
To compare clinical outcome and health-related quality of life 10 years after uterine artery embolization or hysterectomy in the treatment of heavy menstrual bleeding caused by uterine fibroids in a randomized controlled trial. |
A total of 177 patients were randomized from 2002 through 2004. Eventually 81 uterine artery embolization and 75 hysterectomy patients underwent the allocated treatment shortly after randomization. The remaining patients withdrew from the trial. The 10-year questionnaire was mailed when the last included patient had been treated 10 years earlier. The mean duration of follow-up was 133 months (SD 8.58) accompanied by a mean age of 57 years (SD 4.53). Questionnaires were received from 131 of 156 patients (84%). Ten years after treatment, 5 patients underwent secondary hysterectomy resulting in a total of 28 of 81 (35%) (24/77 [31%] after successful uterine artery embolization). Secondary hysterectomies were performed for persisting symptoms in all cases but 1 (for prolapse). After the initial treatment health-related quality of life improved significantly. After 10 years, generic health-related quality of life remained stable, without differences between both groups. The urogenital distress inventory and the defecation distress inventory showed a decrease in both groups, probably related to increasing age, without significant differences between study arms. Satisfaction in both groups remained comparable. The majority of patients declared being (very) satisfied about the received treatment: 78% of the uterine artery embolization group vs 87% in the hysterectomy group. |
1 |
| 14. Kim HS, Oh SY, Choi SJ, et al. Uterine rupture in pregnancies following myomectomy: A multicenter case series. Obstet Gynecol Sci 2016;59:454-62. |
Review/Other-Tx |
14 pregnant women |
To retrospectively examine records of cases with uterine rupture in pregnancies following myomectomy and to describe the clinical features and pregnancy outcomes. |
Fourteen pregnant women experienced uterine rupture during their pregnancy after LSM or LTM. Preterm delivery of less than 34 weeks' gestation occurred in 5 cases, while intrauterine fetal death occurred in 3, and 3 cases had fetal distress. Of the 14 uterine rupture cases, none occurred during labor. All mothers survived and had no sequelae, unlike the perinatal outcomes, although they were receiving blood transfusion or treatment for uterine artery embolization because of uterine atony or massive hemorrhage. |
4 |
| 15. Mara M, Kubinova K, Maskova J, Horak P, Belsan T, Kuzel D. Uterine artery embolization versus laparoscopic uterine artery occlusion: the outcomes of a prospective, nonrandomized clinical trial. Cardiovasc Intervent Radiol. 35(5):1041-52, 2012 Oct. |
Observational-Tx |
200 Patients |
To compare outcomes of two different types of occlusive therapy of uterine fibroids. |
Before the procedure, patients treated with UAE (n = 100) had a dominant fibroid greater in size (68 vs. 48 mm) and a mean age lower (33.1 vs. 34.9 years) than surgically treated patients (n = 100). After 6 months, mean shrinkage of fibroid volume was 53 % after UAE and 39 % after LUAO (p = 0.063); 82 % of women after UAE, but only 23 % after LUAO, had complete myoma infarction (p = 0.001). Women treated with UAE had more complications (31 vs. 11 cases, p = 0.006) and greater incidence of hysteroscopically verified intrauterine necrosis (31 vs. 3 %, p = 0.001). Both groups were comparable in markers of ovarian functions and number of nonelective reinterventions. The groups did not differ in pregnancy (69 % after UAE vs. 67 % after LUAO), delivery (50 vs. 46 %), or abortion (34 vs. 33 %) rates. The mean birth weight of neonates was greater (3270 vs. 2768 g, p = 0.013) and the incidence of intrauterine growth restriction lower (13 vs. 38 %, p = 0.046) in post-UAE patients. |
2 |
| 16. American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins–Gynecology. Management of Symptomatic Uterine Leiomyomas: ACOG Practice Bulletin, Number 228. Obstet Gynecol 2021;137:e100-e15. |
Review/Other-Tx |
N/A |
To provide updated evidence-based recommendations for the medical, procedural, and surgical management of symptomatic leiomyomas. |
No results in abstract. |
4 |
| 17. Peitsidis P, Koukoulomati A. Tranexamic acid for the management of uterine fibroid tumors: A systematic review of the current evidence. World journal of clinical cases 2014;2:893-8. |
Review/Other-Tx |
N/A |
To conduct a detailed systematic review of the current evidence on the administration and efficacy of tranexamic acid in patients with menorrhagia due to uterine fibroids. |
A total of 36 articles were retrieved after the initial electronic search. Careful assessment of the retrieved studies led to the final selection of 5 articles for inclusion in the review |
4 |
| 18. Archer DF, Stewart EA, Jain RI, et al. Elagolix for the management of heavy menstrual bleeding associated with uterine fibroids: results from a phase 2a proof-of-concept study. Fertil Steril. 108(1):152-160.e4, 2017 07. |
Experimental-Tx |
221 women with active treatment (160 women received elagolix
alone; 61 women received elagolix and an add-back therapy; 50 received placebo) |
To evaluate the safety and efficacy of elagolix vs. placebo and elagolix with low-dose E2/progestogen add-back therapy. |
Mean age was 41.8 years; 73.8% were black; mean baseline MBL was 267 mL. Of randomized women (elagolix alone, n = 160; placebo, n = 50; elagolix with add-back therapy, n = 61), 228 of 271 completed the 3-month treatment period. The MBL percentage change from baseline to last 28 days was significantly greater with elagolix alone (range, -72% to -98%; dose-dependent reduction was highest with 300 mg BID) vs. placebo (range, -8% to -41%); mean percentage changes with add-back regimens were -80% to -85%. Overall AEs were dose independent (elagolix alone, 70.0%-81.3%) but lower with placebo (56.0%) and add-back regimens (55.6%-70.6%). Hot flush was the most common AE (elagolix alone, 45.5%-62.5%; placebo, 12.0%; add-back regimens, 18.5%-26.5%). |
1 |
| 19. Carr BR, Stewart EA, Archer DF, et al. Elagolix Alone or With Add-Back Therapy in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 132(5):1252-1264, 2018 11. |
Experimental-Tx |
259 women (cohort 1) and 308 women (cohort 2) |
To evaluate elagolix, an oral gonadotropin-releasing hormone receptor antagonist, alone or with add-back therapy, in premenopausal women with heavy menstrual bleeding (greater than 80 mL per month) associated with uterine leiomyomas. |
From April 8, 2013, to December 8, 2015, 571 women were enrolled, 567 were randomized and treated (cohort 1=259; cohort 2=308), and 80% and 75% completed treatment, respectively. Participants had a mean±SD age of 43±5 years (cohort 2, 42±5 years), and 70% were black (cohort 2, 74%). Primary end point responder rates in cohort 1 (cohort 2) were 92% (90%) for elagolix alone, 85% (73%) for elagolix with 0.5 mg estradiol/0.1 mg norethindrone acetate, 79% (82%) for elagolix with 1.0 mg estradiol/0.5 mg norethindrone acetate, and 27% (32%) for placebo (all P<.001 vs placebo). Elagolix groups had significant decreases compared with placebo in lumbar spine bone mineral density, which was attenuated by adding 1.0 mg estradiol/0.5 mg norethindrone acetate. |
1 |
| 20. Hoshiai H, Seki Y, Kusumoto T, Kudou K, Tanimoto M. Relugolix for oral treatment of uterine leiomyomas: a dose-finding, randomized, controlled trial. BMC Womens Health. 21(1):375, 2021 10 28. |
Experimental-Tx |
214 patients (48 = Relugolix 10mg; 56 = Relugolix 20mg; 55 Relugolix 40mg; 57 = placebo group) |
To evaluate the efficacy and safety of three dose levels of oral relugolix, a small molecule GnRH receptor antagonist, in Japanese women with uterine leiomyomas and heavy menstrual bleeding. |
From November 2011 to September 2012, 216 patients were randomized and 214 patients (99.1%) were analyzed. The proportion (difference vs. placebo) of patients that achieved the primary endpoint in the placebo and 10-, 20-, and 40-mg relugolix groups were 0%, 20.8% (95% confidence interval [CI]: 9.3-32.3, P < .001), 42.6% (95% CI: 29.4-55.8, P < .001), and 83.3% (95% CI: 73.4-93.3, P < .001), respectively. Though treatment-emergent adverse events were similar between the 20- and 40-mg groups, the incidence rates were more frequent compared with the placebo group. Most of these adverse events were mild or moderate in intensity. |
1 |
| 21. Osuga Y, Enya K, Kudou K, Hoshiai H. Relugolix, a novel oral gonadotropin-releasing hormone antagonist, in the treatment of pain symptoms associated with uterine fibroids: a randomized, placebo-controlled, phase 3 study in Japanese women. Fertil Steril. 112(5):922-929.e2, 2019 11. |
Experimental-Tx |
33 patients (Relugolix group) and 32 patients (placebo group) |
To investigate the efficacy and safety of the oral gonadotropin-releasing hormone receptor antagonist, relugolix, in patients experiencing uterine fibroid-associated pain. |
More patients receiving relugolix versus placebo achieved a maximum NRS score of =1 during the 28-day period before the final dose of study drug (57.6% vs. 3.1%). Similarly, more patients receiving relugolix versus placebo achieved a maximum NRS score of 0 (48.5% vs. 3.1%) and experienced more days without pain (96.4% vs. 71.4%). More patients receiving relugolix versus placebo experienced treatment-emergent adverse events (TEAEs; 87.9% vs. 56.3%); however, the rate of treatment discontinuation was low and not different between groups. Most TEAEs were mild to moderate in intensity. TEAEs (=10%) included hot flush, metrorrhagia, hyperhidrosis, and menorrhagia, consistent with relugolix's mechanism of action, and viral upper respiratory tract infection. |
1 |
| 22. Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids. N Engl J Med. 382(4):328-340, 2020 01 23. |
Experimental-Tx |
412 women in UF-1 and 378 women in UF-2 |
To report the results of two identical, doubleblind, randomized, placebo-controlled, 6-month phase 3 trials, Elaris Uterine Fibroids 1 and 2 (UF-1 and UF-2). To assess the efficacy and safety of elagolix with add-back therapy, as compared with placebo, in the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.To assess hypoestrogenic effects in women who received elagolix with add-back therapy, as compared with elagolix alone. |
A total of 412 women in UF-1 and 378 women in UF-2 underwent randomization, received elagolix or placebo, and were included in the analyses. Criteria for the primary end point were met in 68.5% of 206 women in UF-1 and in 76.5% of 189 women in UF-2 who received elagolix plus add-back therapy, as compared with 8.7% of 102 women and 10% of 94 women, respectively, who received placebo (P<0.001 for both trials). Among the women who received elagolix alone, the primary end point was met in 84.1% of 104 women in UF-1 and in 77% of 95 women in UF-2. Hot flushes (in both trials) and metrorrhagia (in UF-1) occurred significantly more commonly with elagolix plus add-back therapy than with placebo. Hypoestrogenic effects of elagolix, especially decreases in bone mineral density, were attenuated with add-back therapy. |
1 |
| 23. Simon JA, Al-Hendy A, Archer DF, et al. Elagolix Treatment for Up to 12 Months in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas. Obstet Gynecol. 135(6):1313-1326, 2020 06. |
Experimental-Tx |
433 women (218 = Elagolix with add-back; 98 = Elagolix alone) |
To investigate the safety and efficacy of elagolix, an oral gonadotropin-releasing hormone antagonist, with hormonal add-back therapy for up to 12 months in women with heavy menstrual bleeding associated with uterine leiomyomas. |
From September 2016 to March 2019, 433 women were enrolled in UF-EXTEND. Of these women, 218 received up to 12 months of elagolix with add-back therapy; the mean±SD age of this group was 42.4±5.4 years and 67.3% were black. The percentage of women who met the primary endpoint in this elagolix with add-back group was 87.9% (95% CI [83.4-92.3]). The most frequently reported adverse events with up to 12 months of elagolix plus add-back therapy were hot flush (6.9%), night sweats (3.2%), headache (5.5%), and nausea (4.1%). Mean percent decreases in bone mineral density from baseline to extension month 6 were significantly less with elagolix plus add-back therapy than with elagolix alone {between-group difference in lumbar spine: -3.3 (95% CI [-4.1 to -2.5])}. |
1 |
| 24. de Milliano I, Huirne JAF, Thurkow AL, et al. Ulipristal acetate vs gonadotropin-releasing hormone agonists prior to laparoscopic myomectomy (MYOMEX trial): Short-term results of a double-blind randomized controlled trial. Acta Obstet Gynecol Scand. 99(1):89-98, 2020 01. |
Experimental-Tx |
55 patients (30 = ulipristal acetate; 25 = Leuprolide acetate ) |
To compare pretreatment with ulipristal acetate (UPA) vs gonadotropin-releasing hormone agonists (GnRHa) prior to laparoscopic myomectomy on several intra- and postoperative outcomes. |
Thirty women received UPA and 25 women leuprolide acetate. Non-inferiority of UPA regarding intraoperative blood loss was not demonstrated. When pretreated with UPA, median intraoperative blood loss was statistically significantly higher (525 mL [348-1025] vs 280 mL[100-500]; P = 0.011) and suturing time of the first fibroid was statistically significantly longer (40 minutes [28-48] vs 22 minutes [14-33]; P = 0.003) compared with GnRHa. Pretreatment with UPA showed smaller reduction in fibroid volume preoperatively compared with GnRHa (-7.2% [-35.5 to 54.1] vs -38.4% [-71.5 to -19.3]; P = 0.001). Laparoscopic myomectomies in women pretreated with UPA were subjectively judged more difficult than in women pretreated with GnRHa. |
1 |
| 25. Al-Hendy A, Lukes AS, Poindexter AN 3rd, et al. Treatment of Uterine Fibroid Symptoms with Relugolix Combination Therapy. N Engl J Med. 384(7):630-642, 2021 02 18. |
Experimental-Tx |
388 women in trial L1 and 382 in trial L2 |
To report the results of two replicate international, double-blind, randomized, placebocontrolled, phase 3 trials (LIBERTY 1 and LIBERTY 2) in which we assessed the efficacy and safety of once-daily relugolix combination therapy in women with fibroid-associated heavy menstrual bleeding. To evaluate a delayed relugolix combination therapy regimen, which consisted of relugolix monotherapy for 12 weeks followed by 12 weeks of relugolix combination therapy, in an additional group of participants to assess the benefit and safety of the addition of estradiol and norethindrone acetate. |
A total of 388 women in trial L1 and 382 in trial L2 underwent randomization. A total of 73% of the participants in the relugolix combination therapy group in trial L1 and 71% of those in trial L2 had a response (primary end point), as compared with 19% and 15%, respectively, of those in the placebo groups (P<0.001 for both comparisons). Both relugolix combination therapy groups had significant improvements, as compared with the placebo groups, in six of seven key secondary end points, including measures of menstrual blood loss (including amenorrhea), pain, distress from bleeding and pelvic discomfort, anemia, and uterine volume, but not fibroid volume. The incidence of adverse events was similar with relugolix combination therapy and placebo. Bone mineral density was similar with relugolix combination therapy and placebo but decreased with relugolix monotherapy. |
1 |
| 26. Liu JH, Soper D, Lukes A, et al. Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 132(5):1241-1251, 2018 11. |
Experimental-Tx |
432 women |
To assess the efficacy and tolerability of ulipristal acetate, a selective progesterone receptor modulator, for treatment of symptomatic uterine leiomyomas. |
From January 2014 through November 2016, 432 women were randomized. Demographic characteristics were similar across treatment groups. In course 1, 68 of 162 (42.0% [97.5% CI 33.3-51.1]) and 86 of 157 (54.8% [97.5% CI 45.5-63.8]) patients treated with 5 mg and 10 mg ulipristal, respectively, compared with 0 of 113 (0.0% [97.5% CI 0.0-3.8]) patients treated with placebo achieved amenorrhea (P<.001 for each dose); most women who achieved amenorrhea did so within 10 days (time to amenorrhea, P<.001 for each dose). Significantly greater improvements in Uterine Fibroid Symptom and Health-Related Quality of Life Revised Activities subscale scores were reported with 5 mg and 10 mg ulipristal compared with placebo (least squares mean change from baseline: 48.3, 56.7, and 13.0, respectively; P<.001 for each dose). Both ulipristal doses were well tolerated; in course 1, hot flush occurred in 7.5%, 11.6%, and 1.7% of patients treated with 5 mg ulipristal, 10 mg ulipristal, and placebo, respectively. |
1 |
| 27. Lukes AS, Soper D, Harrington A, et al. Health-Related Quality of Life With Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 133(5):869-878, 2019 05. |
Experimental-Tx |
589 patients (placebo, n=169; ulipristal 5 mg, n=215; ulipristal 10 mg, n=205) |
To investigate effects of ulipristal acetate on health-related quality of life (QOL) and symptom severity in women with symptomatic uterine leiomyomas and abnormal uterine bleeding. |
In pooled analyses, the intent-to-treat population included 589 patients (placebo, n=169; ulipristal 5 mg, n=215; ulipristal 10 mg, n=205). Significantly greater improvements from baseline in all Uterine Fibroid Symptom Health-Related Quality of Life scales were observed with both ulipristal doses compared with placebo (P<.001). A meaningful change in Revised Activities was achieved by 51 patients receiving placebo (34.9%), compared with 144 (73.5%; OR 5.0 [97.5% CI 2.9-8.6]) and 141 (80.6%; OR 7.9 [97.5% CI 4.3-14.6]) patients receiving ulipristal 5 mg, and 10 mg, respectively. In VENUS II, at end of courses 1 and 2, both ulipristal doses demonstrated significant improvements from baseline compared with placebo for all Uterine Fibroid Symptom Health-Related Quality of Life scales (P<.01). Mean Revised Activities scores showed that beneficial ulipristal effects were maintained in course 2, and improvements occurred on switching to ulipristal; results for other scales were similar. |
1 |
| 28. Donnez J, Tatarchuk TF, Bouchard P, et al. Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med 2012;366:409-20. |
Experimental-Tx |
Ulipristal Acetate 5 mg (N=95); Placebo (N=48); Ulipristal Acetate 10 mg (N=94) |
To conduct the PGL4001 (Ulipristal Acetate) Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARL I) trial to determine the effects of 5 mg of ulipristal acetate per day and 10 mg of ulipristal acetate per day on uterine bleeding and fibroid volume in women with symptomatic fibroids who were planning to undergo surgery. |
At 13 weeks, uterine bleeding was controlled in 91% of the women receiving 5 mg of ulipristal acetate, 92% of those receiving 10 mg of ulipristal acetate, and 19% of those receiving placebo (P<0.001 for the comparison of each dose of ulipristal acetate with placebo). The rates of amenorrhea were 73%, 82%, and 6%, respectively, with amenorrhea occurring within 10 days in the majority of patients receiving ulipristal acetate. The median changes in total fibroid volume were -21%, -12%, and +3% (P=0.002 for the comparison of 5 mg of ulipristal acetate with placebo, and P=0.006 for the comparison of 10 mg of ulipristal acetate with placebo). Ulipristal acetate induced benign histologic endometrial changes that had resolved by 6 months after the end of therapy. Serious adverse events occurred in one patient during treatment with 10 mg of ulipristal acetate (uterine hemorrhage) and in one patient during receipt of placebo (fibroid protruding through the cervix). Headache and breast tenderness were the most common adverse events associated with ulipristal acetate but did not occur significantly more frequently than with placebo. |
1 |
| 29. Donnez J, Vazquez F, Tomaszewski J, et al. Long-term treatment of uterine fibroids with ulipristal acetate ?. Fertil Steril 2014;101:1565-73 e1-18. |
Experimental-Tx |
209 women with symptomatic fibroids including heavy menstrual bleeding |
To investigate the efficacy and safety of ulipristal acetate (UPA) for long-term treatment of symptomatic uterine fibroids. |
After the first UPA course, amenorrhea occurred in 79% of women, with median onset (from treatment start) of 4 days (interquartile range, 2-6 days). Median fibroid volume change was -45% (interquartile range, -66%; -25%). Amenorrhea rates were 89%, 88%, and 90% for the 131, 119, and 107 women who received treatment courses 2, 3, and 4, respectively. Median times to amenorrhea were 2, 3, and 3 days for treatment courses 2, 3, and 4, respectively. Median fibroid volume changes from baseline were -63%, -67%, and -72% after treatment courses 2, 3, and 4, respectively. All endometrial biopsies showed benign histology without hyperplasia; NETA did not affect fibroid volume or endometrial histology. |
1 |
| 30. Osuga Y, Nakano Y, Yamauchi Y, Takanashi M. Ulipristal acetate compared with leuprorelin acetate for Japanese women with symptomatic uterine fibroids: a phase III randomized controlled trial. Fertil Steril. 116(1):189-197, 2021 07. |
Experimental-Tx |
82 patients in UPA group and 79 patients in LEU group |
To evaluate the efficacy and safety of ulipristal acetate (UPA) for uterine fibroids (UFs), a phase III study was conducted with leuprorelin (LEU) as a comparator. This is the first confirmatory trial of UPA for UFs among Asians. |
The percentage of patients with amenorrhea for 35 days was 87.0% in the UPA group and 81.8% in the LEU group, and the efficacy of UPA for causing amenorrhea for 35 days was confirmed to be noninferior to that of LEU. AEs occurred in 78.0% of the patients in the UPA group and 88.8% of the patients in the LEU group. |
1 |
| 31. Gatti M, Poluzzi E, De Ponti F, Raschi E. Liver Injury with Ulipristal Acetate: Exploring the Underlying Pharmacological Basis. Drug Saf. 43(12):1277-1285, 2020 12. |
Observational-Tx |
Ulipristal acetate = 578 patients; Mifepristone = 6,220 patients; Leuprolide acetate = 44,079 patients |
|
|
3 |
| 32. Yoon EL, Yuk JS. Use of Ulipristal Acetate and Risk of Liver Disease: A Nationwide Cohort Study. J Clin Endocrinol Metab. 106(6):1773-1782, 2021 05 13. |
Observational-Tx |
17,207 patients (GnRH agonists) and 20,926 patients (UPA) |
|
|
2 |
| 33. Sridhar D, Kohi MP. Updates on MR-Guided Focused Ultrasound for Symptomatic Uterine Fibroids. Semin Intervent Radiol 2018;35:17-22. |
Review/Other-Tx |
N/A |
To discuss MRgFUS, including technology, patient selection, technique, outcomes, complications, and recent data on fertility and comparative effectiveness. |
No results in abstract. |
4 |
| 34. Jacoby VL, Kohi MP, Poder L, et al. PROMISe trial: a pilot, randomized, placebo-controlled trial of magnetic resonance guided focused ultrasound for uterine fibroids. Fertil Steril. 105(3):773-780, 2016 Mar. |
Experimental-Tx |
20 patients (13 in MRgFUS group and 7 in placebo group) |
To evaluate the feasibility of a full-scale placebo-controlled trial of magnetic resonance-guided focused ultrasound for fibroids (MRgFUS) and obtain estimates of safety and efficacy. |
Twenty women with a mean age of 44 years (±standard deviation 5.4 years) were enrolled, and 13 were randomly assigned to MRgFUS and 7 to placebo. Four weeks after treatment, all participants reported improvement in the UFS-QOL: a mean of 10 points in the MRgFUS group and 9 points in the placebo group (for difference in change between groups). By 12 weeks, the MRgFUS group had improved more than the placebo group (mean 31 points and 13 points, respectively). The mean fibroid volume decreased 18% in the MRgFUS group with no decrease in the placebo group at 12 weeks. Two years after MRgFUS, 4 of 12 women who had a follow-up evaluation (30%) had undergone another fibroid surgery or procedure. |
1 |
| 35. Laughlin-Tommaso S, Barnard EP, AbdElmagied AM, et al. FIRSTT study: randomized controlled trial of uterine artery embolization vs focused ultrasound surgery. Am J Obstet Gynecol. 220(2):174.e1-174.e13, 2019 02. |
Experimental-Tx |
29 allocated to UAE and 28 allocated to MRgFUS |
To report treatment effectiveness and ovarian function after uterine artery embolization vs magnetic resonance imaging-guided focused ultrasound surgery from the Fibroid Interventions: Reducing Symptoms Today and Tomorrow study. |
From 2010-2014, 83 women (mean age, 44.4 years) were treated in the comprehensive cohort design (43 for magnetic resonance imaging-guided focused ultrasound surgery [27 randomized]; 40 for uterine artery embolization [22 randomized]); baseline clinical and uterine characteristics were similar between treatment arms, except for higher fibroid load in the uterine artery embolization arm. The risk of reintervention was higher with magnetic resonance imaging-guided focused ultrasound surgery than uterine artery embolization (hazard ratio, 2.81; 95% confidence interval, 1.01-7.79). Uterine artery embolization showed a significantly greater absolute decrease in anti-Müllerian hormone levels at 24 months compared with magnetic resonance imaging-guided focused ultrasound surgery. Quality of life and pain scores improved in both arms but to a greater extent in the uterine artery embolization arm. Higher pretreatment anti-Müllerian hormone level and younger age at treatment increased the overall risk of reintervention. |
1 |
| 36. Barnard EP, AbdElmagied AM, Vaughan LE, et al. Periprocedural outcomes comparing fibroid embolization and focused ultrasound: a randomized controlled trial and comprehensive cohort analysis. Am J Obstet Gynecol. 216(5):500.e1-500.e11, 2017 05. |
Experimental-Tx |
29 patients in UAE group and 28 patients in MRgFUS group |
To summarize treatment parameters and compare recovery trajectory and adverse events in the first 6 weeks after treatment. |
Of 83 women in the comprehensive cohort design who underwent treatment, 75 completed postprocedure diaries. Focused ultrasound surgery was a longer procedure than embolization (mean [SD], 405 [146] vs 139 [44] min; P <.001). Of women undergoing focused ultrasound (n = 43), 23 (53%) underwent 2 treatment days. Immediate self-rated postprocedure pain was higher after uterine artery embolization than focused ultrasound (median [interquartile range], 5 [1-7] vs 1 [1-4]; P = .002). Compared with those having focused ultrasound (n = 39), women undergoing embolization (n = 36) were more likely to use outpatient opioid (75% vs 21%; P < .001) and nonsteroidal antiinflammatory medications (97% vs 67%; P < .001) and to have a longer median (interquartile range) recovery time (days off work, 8 [6-14] vs 4 [2-7]; P < .001; days until return to normal, 15 [10-29] vs 10 [10-15]; P = .02). There were no significant differences in the incidence or severity of adverse events between treatment arms; 86% of adverse events (42 of 49) required only observation or nominal treatment, and no events caused permanent sequelae or death. After adjustment for baseline pain and uterine fibroid load, uterine artery embolization was still significantly associated with higher opioid use and longer time to return to work and normal activities (P < .001 for each). Results were similar when restricted to the randomized controlled trial. |
1 |
| 37. Chen J, Li Y, Wang Z, et al. Evaluation of high-intensity focused ultrasound ablation for uterine fibroids: an IDEAL prospective exploration study. BJOG. 125(3):354-364, 2018 02. |
Observational-Tx |
1353 women (HIFU group), 1058 women (Surgery group which includes 472 hysterectomy and 586 myomectomy) |
To evaluate the clinical outcomes of high-intensity focused ultrasound (HIFU) and surgery in treating uterine fibroids, and prepare for a definitive randomised trial. |
HIFU patients were significantly younger (P < 0.001), slimmer (P < 0.001), better educated (P < 0.001), and wealthier (P = 0.002) than surgery patients. Both UFS and QoL improved more rapidly after HIFU than after surgery (P = 0.002 and P = 0.001, respectively at 6 months), but absolute differences were small. Major adverse events occurred in 3 (0.2%) of HIFU and in 133 (12.6%) of surgical cases (P < 0.001). Median time for hospital stay was 4 days (interquartile range, 0-5 days), 10 days (interquartile range, 8-12.5 days) and 8 days (interquartile range, 7-10 days). |
1 |
| 38. Gorny KR, Borah BJ, Brown DL, Woodrum DA, Stewart EA, Hesley GK. Incidence of additional treatments in women treated with MR-guided focused US for symptomatic uterine fibroids: review of 138 patients with an average follow-up of 2.8 years. J Vasc Interv Radiol 2014;25:1506-12. |
Observational-Tx |
138 patients |
To assess long-term outcomes of magnetic resonance (MR)-guided focused ultrasound (US) treatments of uterine fibroids. |
The average length of follow-up was 2.8 years (range, 1-7.2 y). The cumulative incidence of additional treatments at 36 months and 48 months after MR-guided focused US was 19% and 23%, respectively. Women who did not need additional treatment were older than women who did (46.3 y ± 5.6 vs 43.0 y ± 5.8; P = .006; hazard ratio, 0.855; 95% confidence interval, 0.789-0.925). Additionally, women with heterogeneous or bright fibroids on T2-weighted MR imaging were more likely to require additional treatment compared with women with homogeneously dark fibroids (hazard ratio, 5.185 or 5.937, respectively; 95% confidence interval, 1.845-14.569 or 1.401-25.166, respectively). Physician predictions of treatment success, recorded during the screening process, had significant predictive value (P = .018). |
2 |
| 39. Froeling V, Meckelburg K, Schreiter NF, et al. Outcome of uterine artery embolization versus MR-guided high-intensity focused ultrasound treatment for uterine fibroids: long-term results. Eur J Radiol. 82(12):2265-9, 2013 Dec. |
Observational-Tx |
77 Patients |
To compare the long-term outcome after uterine artery embolization (UAE) versus magnetic resonance-guided high-intensity focused ultrasound (MR-g HIFU) for symptomatic uterine fibroids. |
Re-intervention was significantly lower after UAE (12.2%) than after MR-g HIFU (66.7%) at long-term follow-up (p<0.001). After UAE changes in SS (50 pre-treatment vs. 6.3 post-treatment) and Total HRQoL (57.8 pre-treatment vs. 100 post-treatment) were significantly better than changes in SS (42.2 pre-treatment vs. 26.6 post-treatment) and Total HRQoL score (66.4 pre-treatment vs. 87.9 post-treatment) after MR-g HIFU (p = 0.019 and 0.049 respectively). |
2 |
| 40. Mohr-Sasson A, Machtinger R, Mashiach R, et al. Long-term outcome of MR-guided focused ultrasound treatment and laparoscopic myomectomy for symptomatic uterine fibroid tumors. Am J Obstet Gynecol. 219(4):375.e1-375.e7, 2018 10. |
Observational-Tx |
Laparoscopic myomectomy (n=64) and Magnetic resonance-guided focused ultrasound (n=68) |
To compare the long-term outcome of laparoscopic myomectomy with magnetic resonance-guided focused ultrasound for symptomatic uterine fibroid tumors. |
One hundred fifty-four women met the inclusion criteria. Complete follow-up evaluation was achieved for 64 women who underwent laparoscopic myomectomy and for 68 women who were treated by magnetic resonance-guided focused ultrasound. Follow-up time was similar for the 2 groups (median, 31 months [interquartile range, 17-51 months] vs 36 months [interquartile range, 24-41]; P=.95). The rate of additional interventions was 5 (7.8%) and 9 (13.2%), respectively (P=0.312). Similarly, the Uterine Fibroid Symptom and Quality of Life symptom severity score questionnaire score at follow-up interviews revealed comparable median scores of 17 (interquartile range, 12-21) vs 17 (interquartile range, 13-22) for laparoscopic myomectomy and magnetic resonance-guided focused ultrasound, respectively (P=.439). Analysis of each of the symptoms separately (bleeding, changes in menstruation, abdominal pain, bladder activity, nocturia, fatigue) did not change these findings, nor did a multivariate analysis. |
2 |
| 41. Rabinovici J, David M, Fukunishi H, et al. Pregnancy outcome after magnetic resonance-guided focused ultrasound surgery (MRgFUS) for conservative treatment of uterine fibroids. Fertil Steril 2010;93:199-209. |
Review/Other-Tx |
51 Patients |
To report all pregnancies to date after magnetic resonance-guided focused ultrasound surgery (MRgFUS) for the conservative treatment of clinically significant uterine fibroids. |
Fifty-four pregnancies in 51 women have occurred after MRgFUS treatment of uterine leiomyomas. The mean time to conception was 8 months after treatment. Live births occurred in 41% of pregnancies, with a 28% spontaneous abortion rate, an 11% rate of elective pregnancy termination, and 11 (20%) ongoing pregnancies beyond 20 gestational weeks. The mean birth weight was 3.3 kg, and the vaginal delivery rate was 64%. |
4 |
| 42. Ananthakrishnan G, Murray L, Ritchie M, et al. Randomized comparison of uterine artery embolization (UAE) with surgical treatment in patients with symptomatic uterine fibroids (REST trial): subanalysis of 5-year MRI findings. Cardiovasc Intervent Radiol. 36(3):676-81, 2013 Jun. |
Experimental-Tx |
99 patients in successful UAE group and 8 patients in successful myomectomy group |
To report 5-year contrast-enhanced magnetic resonance imaging findings of the REST trial recruits who underwent either uterine artery embolization (UAE) or myomectomy. |
In the UAE group, mean ± standard deviation uterine volume was 670 ± 503, 422 ± 353, and 292 ± 287 mL at baseline, 6 months, and 5 years, respectively. Mean dominant fibroid diameter was 7.6 ± 3.0, 5.8 ± 2.9, and 5 ± 2.9 cm at baseline, 6 months, and 5 years. Fibroid infarction at 6 months was complete in 35 % of women, almost complete in 29 %, and partial in 36 %. Need for reintervention was 19, 10, and 33 % in these groups, respectively (p = 0.123). No myomectomy cases had further intervention. At 5 years, the prevalence of new fibroid was 60 % in the myomectomy group and 7 % in the UAE group (p = 0.008). |
1 |
| 43. Liu L, Wang T, Lei B. Uterine Artery Embolization Compared with High-intensity Focused Ultrasound Ablation for the Treatment of Symptomatic Uterine Myomas: A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 28(2):218-227, 2021 02. |
Meta-analysis |
7 articles (5 trials involving 4592 women with symptomatic uterine myomas) |
To compare the clinical effects of uterine artery embolization (UAE) with those of high-intensity focused ultrasound (HIFU) ablation for the treatment of symptomatic uterine myomas. |
Compared with the HIFU ablation group, the decrease in "uterine fibroid symptom" scores as well as the increase in quality-of-life scores at the time of follow-up were higher in the UAE group, with overall mean difference 19.54 (95% CI, 15.21-23.87; p <.001) and 15.72 (95% CI, 8.30-23.13; p <.001), respectively. The women in the UAE group had a significantly lower reintervention rate (RR 0.25; 95% CI, 0.15-0.42; p <.001). The women undergoing UAE had a significantly lower pregnancy rate than those undergoing HIFU ablation (RR 0.06; 95% CI, 0.01-0.45; p = .006). The difference in the incidence of adverse events between the 2 groups was not statistically significant (p = .53). |
Good |
| 44. Torre A, Fauconnier A, Kahn V, Limot O, Bussierres L, Pelage JP. Fertility after uterine artery embolization for symptomatic multiple fibroids with no other infertility factors. Eur Radiol. 27(7):2850-2859, 2017 Jul. |
Observational-Tx |
15 patients with multiple symptomatic fibroids, no other infertility factors, wishing to conceive |
To evaluate the fertility of women eligible for surgical multiple myomectomy, but who carefully elected a fertility-sparing uterine artery embolization (UAE). |
Fifteen patients, aged 34.8 years (95%CI 32.2-37.5, median 36.0, q1-q3 29.4-39.5) were included from November 2008 to May 2012. During the year following UAE, 9 women actively attempting to conceive experienced 5 live-births (intention-to-treat fertility rate 33.3%, 95%CI 11.8%-61.6%). Markers of ovarian reserve remained stable. The symptoms score was reduced by 66% (95%CI 48%-85%) and the quality of life score was improved by 112% (95%CI 21%-204%). Uterine volume was reduced by 38% (95%CI 24%-52%). Women were followed for 43.1 months (95%CI 32.4-53.9), 10 live-births occurred in 8 patients, and 5 patients required secondary surgeries for fibroids. |
1 |
| 45. Serres-Cousine O, Kuijper FM, Curis E, Atashroo D. Clinical investigation of fertility after uterine artery embolization. Am J Obstet Gynecol. 225(4):403.e1-403.e22, 2021 10. |
Review/Other-Tx |
398 female patients under the age of 43 years were treated by UAE |
To study the clinical, anatomic, and obstetrical results of uterine artery embolization in patients of childbearing age not eligible for myomectomy. |
The overall clinical success rate (ie, resolution of preembolization symptoms such as heavy menstrual bleeding, iron-deficiency anemia, pelvic pressure) was 91.2%, and there were no major complications. One year after uterine artery embolization, we observed a mean 73% reduction in myoma volume. A total of 108 patients (49.3%) presented with dangerous utero-ovarian anastomosis and 33 (14.5%) benefited from ovarian protection. In our group, there were 148 pregnancies and 109 live births; 74 children were born at term; 23 were born preterm, on average at 35.12±2.78 weeks. Including preterm births, the mean birthweight and birth length of the children were within normal limits. Restoration of uterine anatomy and ovarian protection were identified as the main predictive factors for obstetrical success. Restoration was also a major predictive factor for clinical success and was associated with a lower rate of miscarriage. |
4 |
| 46. Pisco JM, Duarte M, Bilhim T, et al. Spontaneous Pregnancy with a Live Birth after Conventional and Partial Uterine Fibroid Embolization. Radiology. 285(1):302-310, 2017 10. |
Observational-Tx |
359 women with uterine fibroids and/or adenomyosis unable to conceive |
To determine pregnancy rates after conventional and partial uterine fibroid embolization (UFE). |
During follow-up, 149 women became pregnant, 131 women had live births, and 16 women had several pregnancies, resulting in a total of 150 live newborns. It was the first pregnancy for 85.5% (112 of 131) of women. Spontaneous pregnancy rates at 1 year and 2 years after UFE were 29.5% and 40.1%, respectively. The probability of successful pregnancy with live birth at 1 year and 2 years was 24.4% and 36.7%, respectively. Clinical success for fibroid-related symptoms was 78.6% (282 of 359). A dominant submucosal fibroid and ischemia greater than or equal to 90% had greater likelihood of spontaneous pregnancy. Complication rates in patients treated with partial UFE (14.6%) were not greater than rates in patients treated with conventional UFE (23.1%, P = .04). |
2 |
| 47. Mara M, Maskova J, Fucikova Z, Kuzel D, Belsan T, Sosna O. Midterm clinical and first reproductive results of a randomized controlled trial comparing uterine fibroid embolization and myomectomy. Cardiovasc Intervent Radiol 2008;31:73-85. |
Experimental-Tx |
121 Patients |
To compare the midterm results of a radiological and surgical approach to uterine fibroids. |
Fifty-eight embolizations and 63 myomectomies (42 laparoscopic, 21 open) were performed. One hundred eighteen patients have finished at least a 12-month follow-up; the mean follow-up in the entire study population was 24.9 months. Embolized patients underwent a significantly shorter procedure and required a shorter hospital stay and recovery period. They also presented with a lower CRP concentration on the second day after the procedure (p < 0.0001 for all parameters). There were no significant differences between the two groups in the rate of technical success, symptomatic effectiveness, postprocedural follicle stimulating hormone levels, number of reinterventions for fibroid recurrence or regrowth, or complication rates. Forty women after myomectomy and 26 after UAE have tried to conceive, and of these we registered 50 gestations in 45 women. There were more pregnancies (33) and labors (19) and fewer abortions (6) after surgery than after embolization (17 pregnancies, 5 labors, 9 abortions) (p < 0.05). Obstetrical and perinatal results were similar in both groups, possibly due to the low number of labors after UAE to date. |
2 |
| 48. Jain P, Rajaram S, Gupta B, Goel N, Srivastava H. Randomized controlled trial of thermal balloon ablation versus vaginal hysterectomy for leiomyoma-induced heavy menstrual bleeding. Int J Gynaecol Obstet. 135(2):140-144, 2016 Nov. |
Observational-Tx |
40 patients (thermal balloon ablation n=20, vaginal hysterectomy n=20) |
To compare the efficacy of thermal balloon ablation (TBA) with that of vaginal hysterectomy in the treatment of leiomyoma-induced heavy menstrual bleeding (HMB). |
Each group contained 20 women. No women in the TBA group had HMB at 6 months. Nineteen women were amenorrheic by 6 months and one was hypomenorrheic. |
2 |
| 49. Ibiebele I, Nippita TA, Baber R, Torvaldsen S. A study of pregnancy after endometrial ablation using linked population data. Acta obstetricia et gynecologica Scandinavica 2021;100:286-93. |
Observational-Tx |
18 559 women with an endometrial ablation |
To identify factors associated with post-endometrial ablation pregnancy and to describe pregnancy and birth outcomes for post-endometrial ablation pregnancies. |
Of 18 559 women with an endometrial ablation, 575 (3.1%) had a post-ablation pregnancy of at least 20 weeks' gestation. Nulliparity (adjusted hazard ratio [aHR] 12.2, 95% confidence interval [CI] 9.1-16.2), older age (35-39 years: aHR 0.39, 95% CI 0.29-0.51; 40-44 years: aHR 0.06, 95% CI 0.04-0.11), marital status (single: aHR 0.67, 95% CI 0.55-0.83; widowed/divorced/separated: aHR 0.58, 95% CI 0.36-0.94) and a diagnosis of heavy menstrual bleeding (aHR 0.09, 95% CI 0.07-0.13) were associated with post-ablation pregnancy. There were high rates of cesarean delivery (43%), preterm birth (13%), twin or higher order pregnancies (9%) and stillbirth (13.3/1000 births) among these post-ablation pregnancies. |
2 |
| 50. Stewart EA, Laughlin-Tommaso SK, Catherino WH, Lalitkumar S, Gupta D, Vollenhoven B. Uterine fibroids. [Review]. Nat Rev Dis Prim. 2:16043, 2016 06 23. |
Review/Other-Tx |
N/A |
To review the epidemiology, pathophysiology and management of uterine fibroids and discusses the key unanswered research questions regarding this disease. |
No results in abstract |
4 |
| 51. Laughlin-Tommaso SK, Khan Z, Weaver AL, Smith CY, Rocca WA, Stewart EA. Cardiovascular and metabolic morbidity after hysterectomy with ovarian conservation: a cohort study. Menopause 2018;25:483-92. |
Observational-Tx |
2,094 women who underwent hysterectomy with ovarian conservation for benign indications |
To determine the long-term risk of cardiovascular disease and metabolic conditions in women undergoing hysterectomy with bilateral ovarian conservation compared with age-matched referent women. |
Over a median follow-up of 21.9 years, women who underwent hysterectomy experienced increased risks of de novo hyperlipidemia (HR 1.14; 95% CI, 1.05-1.25), hypertension (HR 1.13; 95% CI, 1.03-1.25), obesity (HR 1.18; 95% CI, 1.04-1.35), cardiac arrhythmias (HR 1.17; 95% CI, 1.05-1.32), and coronary artery disease (HR 1.33; 95% CI, 1.12-1.58). Women who underwent hysterectomy at age =35 years had a 4.6-fold increased risk of congestive heart failure and a 2.5-fold increased risk of coronary artery disease. |
2 |
| 52. Laughlin-Tommaso SK, Satish A, Khan Z, Smith CY, Rocca WA, Stewart EA. Long-term risk of de novo mental health conditions after hysterectomy with ovarian conservation: a cohort study. Menopause 2020;27:33-42. |
Observational-Tx |
2,094 women who underwent hysterectomy with ovarian conservation for benign indications at age ≥18 years |
|
|
1 |
| 53. Tuesley KM, Protani MM, Webb PM, et al. Hysterectomy with and without oophorectomy and all-cause and cause-specific mortality. Am J Obstet Gynecol 2020;223:723 e1-23 e16. |
Observational-Tx |
666,588 women |
|
|
2 |
| 54. Ruuskanen A, Hippelainen M, Sipola P, Manninen H. Uterine artery embolisation versus hysterectomy for leiomyomas: primary and 2-year follow-up results of a randomised prospective clinical trial. Eur Radiol. 20(10):2524-32, 2010 Oct. |
Experimental-Tx |
57 Patients |
To compare uterine artery embolisation (UAE) and hysterectomy for the treatment of leiomyomas at 2-year follow-up in a prospective, randomised, single-centre study. |
Two hysterectomy patients (7%) developed major complications. Hospital discharge occurred earlier after UAE than after hysterectomy (p < 0.001). Length of sick leave was longer after hysterectomy than after UAE (p < 0.001). Twenty-two (82%) UAE patients and 28 (93%) hysterectomy patients reported overall relief of symptoms (p = 0.173). In 12/18 (67%) UAE patients menorrhagia was completely resolved or reduced. Improvement of pressure symptoms was reported significantly more by UAE patients than by hysterectomy patients (19/20 [95%] versus 18/26 [69%], respectively; p = 0.029). Five (19%) UAE patients underwent additional interventions due to worsening symptoms. Twenty-four (89%) UAE patients and 29 (97%) hysterectomy patients would have chosen treatment again (p = 0.336). |
2 |
| 55. Yeh YT, Li PC, Wu KC, et al. Hysterectomies are associated with an increased risk of osteoporosis and bone fracture: A population-based cohort study. PLoS One 2020;15:e0243037. |
Observational-Tx |
9,189 hysterectomized women and 33,942 age-matched women without a hysterectomy |
To investigate the risk of osteoporosis or bone fractures (vertebrae, hip and others) in hysterectomized women in Taiwan. |
We identified 9,189 hysterectomized women and 33,942 age-matched women without a hysterectomy. All women were followed for a median time of about 7 years. The adjusted hazard ratio (aHR) of subsequent osteoporosis or bone fracture was higher in the hysterectomy women (2.26, 95% confidence interval [CI] = 2.09-2.44) than in the comparison group. In the subgroup analysis, oophorectomy and estrogen therapy increase the risk of osteoporosis or fracture in both groups. Regarding the fracture site, the aHR of vertebral fracture (4.92, 95% CI = 3.78-6.40) was higher in the hysterectomized women than in the comparison group. As follow-up time increasing, the aHR of vertebral fracture in hysterectomized women were 4.33 (95% CI = 2.99-6.28), 3.89 (95% CI = 2.60-5.82) and 5.42 (95% CI = 2.66-11.01) for <5, 5-9 and =9 years of follow-up, respectively. |
1 |
| 56. Rocca WA, Grossardt BR, Shuster LT, Stewart EA. Hysterectomy, oophorectomy, estrogen, and the risk of dementia. Neurodegener Dis 2012;10:175-8. |
Review/Other-Tx |
2 studies |
To explore the association of hysterectomy and oophorectomy with the subsequent risk of cognitive impairment or dementia. |
Combined results from the Mayo Clinic Cohort Study of Oophorectomy and Aging and from a Danish nationwide cohort study suggest that the extent of gynecologic surgery may correlate with a stepwise increase in the risk of cognitive impairment or dementia. Compared with women with no gynecologic surgeries, the risk of cognitive impairment or dementia was increased in women who had hysterectomy alone, further increased in women who had hysterectomy with unilateral oophorectomy, and further increased in women who had hysterectomy with bilateral oophorectomy. The risk increased with younger age at the time of the surgery. |
4 |
| 57. Aarts JW, Nieboer TE, Johnson N, et al. Surgical approach to hysterectomy for benign gynaecological disease. The Cochrane database of systematic reviews 2015;2015:CD003677. |
Meta-analysis |
47 studies (5102 women) |
To assess the effectiveness and safety of different surgical approaches to hysterectomy for women with benign gynaecological conditions. |
The evidence for most comparisons was of low or moderate quality. The main limitations were poor reporting and imprecision. Vaginal hysterectomy (VH) versus abdominal hysterectomy (AH) (nine RCTs, 762 women)Return to normal activities was shorter in the VH group (mean difference (MD) -9.5 days, 95% confidence interval (CI) -12.6 to -6.4, three RCTs, 176 women, I(2) = 75%, moderate quality evidence). There was no evidence of a difference between the groups for the other primary outcomes. Laparoscopic hysterectomy (LH) versus AH (25 RCTs, 2983 women)Return to normal activities was shorter in the LH group (MD -13.6 days, 95% CI -15.4 to -11.8; six RCTs, 520 women, I(2) = 71%, low quality evidence), but there were more urinary tract injuries in the LH group (odds ratio (OR) 2.4, 95% CI 1.2 to 4.8, 13 RCTs, 2140 women, I(2) = 0%, low quality evidence). There was no evidence of a difference between the groups for the other primary outcomes. LH versus VH (16 RCTs, 1440 women)There was no evidence of a difference between the groups for any primary outcomes. Robotic-assisted hysterectomy (RH) versus LH (two RCTs, 152 women)There was no evidence of a difference between the groups for any primary outcomes. Neither of the studies reported satisfaction rates or quality of life.Overall, the number of adverse events was low in the included studies. |
Good |
| 58. Albright BB, Witte T, Tofte AN, et al. Robotic Versus Laparoscopic Hysterectomy for Benign Disease: A Systematic Review and Meta-Analysis of Randomized Trials. J Minim Invasive Gynecol 2016;23:18-27. |
Review/Other-Tx |
4 RCTs |
|
|
4 |
| 59. Mengerink BB, van der Wurff AA, ter Haar JF, van Rooij IA, Pijnenborg JM. Effect of undiagnosed deep adenomyosis after failed NovaSure endometrial ablation. J Minim Invasive Gynecol 2015;22:239-44. |
Observational-Tx |
Hysterectomy after NovaSure, n=22 (study group) and Hysterectomy without NovaSure, n=173 (control group) |
To determine the prevalence of adenomyosis and deep adenomyosis after NovaSure (Hologic Inc., Newark, DE) endometrial ablation in hysterectomy specimens after NovaSure endometrial ablation failure. |
Of 213 patients who underwent NovaSure therapy, 22 (10.3%) underwent a hysterectomy because NovaSure failed. Of these, 10 (45.5%) exhibited adenomyosis in their hysterectomy specimens. The control group patients had a similar adenomyosis prevalence (74/173, 42.8%). However, the NovaSure failure group had a significantly higher prevalence of deep adenomyosis (>2.5 mm endometrial penetration) (9/22, 40.9%) than the control group (37/173, 21.4%, p < .05). |
1 |
| 60. Fraser IS, Romer T, Parke S, et al. Effective treatment of heavy and/or prolonged menstrual bleeding with an oral contraceptive containing estradiol valerate and dienogest: a randomized, double-blind Phase III trial. Hum Reprod 2011;26:2698-708. |
Observational-Tx |
149 patients (estradiol valerate/dienogest group) and 82 patients (placebo group) |
To investigate the efficacy and safety of estradiol valerate/dienogest (E(2)V/DNG) for the treatment of heavy menstrual bleeding without recognizable organic pathology. |
The intention-to-treat population comprised 231 women. The E(2)V/DNG response rate was much higher than with placebo (P < 0.0001). The mean reduction in MBL volume in E(2)V/DNG recipients was 69.4% (median 79.2%) versus 5.8% (median 7.4%) in placebo recipients. The between-treatment difference in MBL volume was 373 ml in favour of E(2)V/DNG (95% confidence interval 490, 255 ml; P < 0.0001). Significant improvements in iron metabolism parameters were observed with E(2)V/DNG but not placebo. Overall, 14 women (9.7%) treated with E(2)V/DNG and 5 (6.2%) treated with placebo prematurely discontinued treatment because of adverse events, headache being the most prevalent. Serious adverse events occurred in both the E(2)V/DNG and placebo groups (each n = 2). |
1 |
| 61. Jensen JT, Parke S, Mellinger U, Machlitt A, Fraser IS. Effective treatment of heavy menstrual bleeding with estradiol valerate and dienogest: a randomized controlled trial. Obstet Gynecol 2011;117:777-87. |
Experimental-Tx |
120 patients (estradiol valerate and dienogest group) , 70 patients (placebo group) |
To estimate the efficacy of a fixed estrogen step-down and progestin step-up 28-day estradiol (E2) valerate and dienogest oral contraceptive regimen in women with heavy menstrual bleeding, prolonged menstrual bleeding, or heavy and prolonged menstrual bleeding without organic pathology. |
There were no marked differences in the characteristics of E2 valerate and dienogest (n=120) and placebo (n=70) recipients. The proportion of "complete responders" in the evaluable group was significantly higher in E2 valerate and dienogest (35/80; 43.8%) compared with placebo (2/48, 4.2%, P<.001) recipients. The mean [standard deviation] reduction in menstrual blood loss with E2 valerate and dienogest from the run-in phase to the efficacy phase was substantial (-353 mL [309 mL]; mean -64.2%; median -70.6%) and significantly greater than that in placebo recipients (-130 mL [338 mL]; mean -7.8%; median -18.7%; P<.001). Significant improvements in hemoglobin, hematocrit, and ferritin were seen with E2 valerate and dienogest, but not with placebo. |
1 |
| 62. Shaaban MM, Zakherah MS, El-Nashar SA, Sayed GH. Levonorgestrel-releasing intrauterine system compared to low dose combined oral contraceptive pills for idiopathic menorrhagia: a randomized clinical trial. Contraception 2011;83:48-54. |
Observational-Tx |
LNG-IUS (n=56) and COC (n=56) groups |
To compare the efficacy of the levonorgestrel-releasing intrauterine system (LNG-IUS) to low dose combined oral contraceptive pills (COC) in the management of idiopathic menorrhagia. |
At baseline, LNG-IUS (n=56) and COC (n=56) groups were comparable in age (mean ± S.D.) (39.3 ± 6.7 vs. 38.7 ± 5.2 years, p=.637), parity (median and range) [3(1-6.4) vs.3(2-6), p=.802] and BMI (mean ± S.D.) (29.6 ± 5.9 vs. 31.1 ± 5.7 kg/m(2), p=.175). Time to treatment failure was longer in LNG compared to COC group with a total of 6 (11%) patients who had treatment failure in the LNG-IUS compared to 18 (32%) in COC group with a hazard ratio of 0.30 (95% CI, 0.15-0.73, p=.007). Using alkaline hematin, the reduction in MBL (mean ± S.D.) was significantly more in the LNG-IUS group (87.4 ± 11.3%) compared to the COC group (34.9 ± 76.9%) (p=.013). Utilizing PBLAC scores, the reduction in the LNG-IUS (86.6 ± 17.0%) group was significantly more compared to the COC group (2.5 ± 93.2%) (p<.001). In the LNG-IUS group, increase in the hemoglobin and ferritin levels (mean ± S.D.) were noted (from 10.2 ± 1.3 to 11.4 ± 1.0 g/dL; p<.001; with reduction of the number of lost days (from 6.8 ± 2.6 to 1.6 ± 2.4 days, p=.003). |
1 |
| 63. Shaaban OM, Ali MK, Sabra AM, Abd El Aal DE. Levonorgestrel-releasing intrauterine system versus a low-dose combined oral contraceptive for treatment of adenomyotic uteri: a randomized clinical trial. Contraception 2015;92:301-7. |
Observational-Tx |
31 women in LNG-IUS group and 31 women in COC group |
To compare the efficacy of a levonorgestrel-releasing intrauterine system (LNG-IUS) and a low-dose combined oral contraceptive (COC) in reducing adenomyosis-related pain and bleeding. |
Both treatments significantly reduced pain after 6 months of use; however, the reduction was greater in the LNG-IUS group (from 6.23±0.67 to 1.68±1.25) compared with the COCs group (from 6.55±0.68 to 3.90±0.54). Both treatment arms significantly decreased the number of bleeding days, uterine volume and Doppler blood flow in the uterus from before to after treatment. These effects were more significant in the LNG-IUS arm compared with the COC arm. |
1 |
| 64. Muneyyirci-Delale O, Archer DF, Owens CD, et al. Efficacy and safety of elagolix with add-back therapy in women with uterine fibroids and coexisting adenomyosis. F S Rep 2021;2:338-46. |
Experimental-Tx |
126 women with uterine fibroids and coexisting adenomyosis and 660 women with uterine fibroids without adenomyosis (786 total women) |
|
|
1 |
| 65. Froeling V, Scheurig-Muenkler C, Hamm B, Kroencke TJ. Uterine artery embolization to treat uterine adenomyosis with or without uterine leiomyomata: results of symptom control and health-related quality of life 40 months after treatment. Cardiovasc Intervent Radiol. 35(3):523-9, 2012 Jun. |
Observational-Tx |
40 women |
To evaluate the clinical outcome for uterine adenomyosis with or without uterine leiomyomata 40 months after uterine artery embolization (UAE).Note: Embolization was performed by deploying a particulate embolic agent in a diameter range of 355–900 lm (Embosphere, 500–700 lm, Biosphere Medical, Rockland, MA; BeadBlock 700–900 lm, Biocompatibles, Farnham, Great Britain; Contour 355–510 lm, Boston Scientific/Medi-Tech, Natick, MA) suspended in a dilute solution of an iodinated contrast agent (Imeron 300, Schering Bayer Health Care Pharmaceuticals, Berlin, Germany). |
Patients were followed for a median of 40 months (range 5-102 months). UAE led to symptomatic control after UAE in 29 (72.5%) of 40 patients while 11 women underwent hysterectomy (n=10) or dilatation and curettage (n=1) for therapy failure. No significant difference between women with pure uterine adenoymosis and women with uterine adenomyosis combined with uterine leiomyomata was observed. Best results were shown for UAE in uterine adenomyosis with uterine leiomyomata predominance as opposed to predominant uterine adenomyosis with minor fibroid disease (clinical failure 0% vs. 31.5%, P=0.058). Throughout the study group, HRQOL score values increased and symptom severity scores decreased after UAE. Least improvement was noted for women with pure adenomyosis. |
2 |
| 66. de Bruijn AM, Smink M, Hehenkamp WJK, et al. Uterine Artery Embolization for Symptomatic Adenomyosis: 7-Year Clinical Follow-up Using UFS-Qol Questionnaire. Cardiovasc Intervent Radiol. 40(9):1344-1350, 2017 Sep. |
Observational-Tx |
29 patients with adenomyosis (15 with fibroids) |
To assess clinical outcomes 7 years after uterine artery embolization (UAE) in the treatment of symptomatic adenomyosis. |
Twenty-nine patients with adenomyosis (15 with fibroids) were treated with UAE between September 2006 and January 2010. The 7-year questionnaire was mailed in November 2016. The mean follow-up was 95 months (SD 9.0) at a mean age of 50 (SD 5.4). Questionnaires were returned by 24/29 patients (83%). The remaining five patients were contacted through telephone. One of these patients was untraceable. Seven years after treatment 5 of 28 patients (18%) underwent a secondary hysterectomy. The HRQOL and SSS scores as measured by UFS-QOL at 3 months after UAE showed significant improvement of -57 points (score: 15) and +40 points (score: 91), respectively. These scores remained comparable stable up unto 7 years. The SSS showed a significant difference of 17 points (0-100) in favor of the adenomyosis in combination with fibroids group (p = 0.020). Menopause was reported by 10/28 patients (36%). Twenty-one of 29 (72%) patients declared to be at least fairly satisfied about UAE. |
2 |
| 67. Smeets AJ, Nijenhuis RJ, Boekkooi PF, Vervest HA, van Rooij WJ, Lohle PN. Long-term follow-up of uterine artery embolization for symptomatic adenomyosis. Cardiovasc Intervent Radiol. 35(4):815-9, 2012 Aug. |
Observational-Tx |
40 women |
To assess long-term outcome of UAE in 40 women with adenomyosis.Note: MRI consisted of T2- and T1-weighted contrast-enhanced images and was performed before embolization and again at 3-month follow-up. |
During follow-up, 7 of 40 women (18%) underwent hysterectomy. Among these 7 women, the junction zones were significantly thicker, both at baseline (mean 23 vs. 16 mm, P = 0.028) and at 3-month follow-up (mean 15 vs. 9 mm, P = 0.034). Of 33 women with preserved uterus, 29 were asymptomatic. Four patients had symptom severity scores of 50 to 85 and overall QoL scores of 60 to 66, indicating substantial clinical symptoms. There was no relation between clinical outcome and the initial presence of fibroids in addition to adenomyosis |
2 |
| 68. de Bruijn AM, Smink M, Lohle PNM, et al. Uterine Artery Embolization for the Treatment of Adenomyosis: A Systematic Review and Meta-Analysis. [Review]. J Vasc Interv Radiol. 28(12):1629-1642.e1, 2017 Dec. |
Meta-analysis |
30 studies |
To summarize and evaluate the effect of UAE on symptomatic pure adenomyosis and adenomyosis combined with fibroids in terms of symptom improvement and MR imaging outcomes. |
The examination of studies resulted in inclusion of 30 observational trials and yielded follow-up data from 1,049 patients with adenomyosis (pure and combined) on improvement of symptoms and secondary hysterectomies |
Inadequate |
| 69. de Bruijn AM, Lohle PN, Huirne JA, et al. Uterine Artery Embolization Versus Hysterectomy in the Treatment of Symptomatic Adenomyosis: Protocol for the Randomized QUESTA Trial. JMIR Res Protoc 2018;7:e47. |
Review/Other-Tx |
Not included in abstract/article |
To evaluate the impact of UAE on Health-Related Quality of Life (HRQOL) in a randomized comparison to hysterectomy in patients with symptomatic adenomyosis. |
No results in abstract.Patient enrollment started November 2015. The follow-up period will be completed two years after inclusion of the last patient. At the time of submission of this article, data cleaning and analyses have not yet started. |
4 |
| 70. Nguyen MD. Magnetic Resonance Imaging-Guided Volumetric High-Intensity Focused Ultrasound Surgery for Pedunculated Subserosal Uterine Leiomyoma. Gynecol Minim Invasive Ther 2020;9:104-05. |
Review/Other-Tx |
One 42‑year‑old woman |
To examine a 42-year-old woman suffering from dominant pelvic tension and was indicated magnetic resonance imaging (MRI) for evaluating the uterine leiomyoma features before MRI-guided volumetric high-intensity focused ultrasound (HIFU). |
No results in abstract. |
4 |
| 71. Park H, Yoon SW, Kim KA, Jung Kim D, Jung SG. Magnetic resonance imaging-guided focused ultrasound treatment of pedunculated subserosal uterine fibroids: a preliminary report. J Vasc Interv Radiol 2012;23:1589-93. |
Observational-Tx |
9 patients with pedunculated subserosal fibroid |
To evaluate magnetic resonance (MR) imaging-guided focused ultrasound (US) as a treatment for pedunculated subserosal fibroids. |
The volume of the treated fibroids (n=9) ranged from 79-380cm(3) (mean, 198cm(3)), and NPV ratio ranged from 45%-80% (mean, 67%). MR imaging follow-up at 6 months showed a 14%-48% (mean, 30%) reduction in the volume of the treated fibroids (P =.008). In all cases, the pedunculated subserosal fibroids remained connected to the uterus with a 13% average decrease in the mean diameter of the stalks (from 3.5 to 3.0cm; P=.008). Eight of nine patients (89%) reported improvement in bulk-related fibroid symptoms after treatment. |
2 |
| 72. Smeets AJ, Nijenhuis RJ, Boekkooi PF, et al. Safety and effectiveness of uterine artery embolization in patients with pedunculated fibroids. J Vasc Interv Radiol 2009;20:1172-5. |
Observational-Tx |
29 Patients |
To assess complications and outcomes of uterine artery embolization (UAE) in women with pedunculated fibroids in a large single-center patient cohort. |
The mean reduction in uterine and pedunculated fibroid volume was 37% and 33%, respectively. The mean reduction in stalk diameter was 0.3 cm (95% confidence interval [CI]: 0.18, 0.52 cm) or 13% from initial mean diameter. Stalk enhancement was not affected by UAE. The mean pedunculated fibroid infarction and mean overall infarction rates were 87% and 92%, respectively, for observer 1 and 88% and 92% for observer 2, with good interobserver variability. All women returned the questionnaire and no early or late complications of UAE were reported (0%; 95% CI: 0.0%-13.9%). |
2 |
| 73. Radeleff B, Eiers M, Bellemann N, et al. Expulsion of dominant submucosal fibroids after uterine artery embolization. Eur J Radiol. 75(1):e57-63, 2010 Jul. |
Observational-Tx |
20 consecutive patients |
To evaluate the frequency, probability, and factors associated with expulsion of submucosal fibroids after uterine artery embolization (UAE) in addition to the technical and clinical results at 1-year follow-up. |
Technical success was observed in all 20 patients (mean age of 41.4+/-5.6 years; range: 29.2-51.1 years). Two (10%) minor and one (5%) major complications occurred. 10/20 dominant submucosal fibroids were completely expelled during the follow-up. Using 3D MRI volumetry the preinterventional mean volume of the later expelled fibroids was 56.8+/-57.0 ml (range 2.3-198.0 ml) and the mean volume of non-expelled fibroids was 123.8+/-147.3 ml (range 24.0-531.8 ml). This difference was statistically significant, but weak (p=0.0494). Fibroids with a volume equal or less than the threshold value (66.0 ml) were 73% likely to be expelled and fibroids larger than 66.0 ml were 78% likely not to be expelled. All 20 patients demonstrated a significant reduction in the fibroid related symptoms. |
2 |
| 74. Lee SJ, Kim MD, Kim GM, Won JY, Park SI, Lee DY. Uterine artery embolization for symptomatic fibroids in postmenopausal women. Clin Imaging. 40(1):106-9, 2016 Jan-Feb. |
Review/Other-Tx |
9 patients |
To evaluate the efficacy of uterine artery embolization (UAE) for symptomatic fibroids in postmenopausal women. |
Urinary frequency was the most common symptom, observed in seven patients (77.8%). Of two patients (22.2%) with vaginal bleeding from submucosal myomas, one patient had been on hormone replacement therapy (HRT). One patient underwent UAE due to growing leiomyoma after HRT. All of the 18 uterine arteries were bigger than the corresponding IMAs in MR angiography. Contrast-enhanced MRI revealed complete necrosis of the predominant fibroid in all patients. Eight (88.9%) of the nine participants demonstrated resolution of symptoms. The mean predominant fibroid and uterine volume reduction rates were 39.7% and 36.9%, respectively. |
4 |
| 75. Brohl AS, Li L, Andikyan V, et al. Age-stratified risk of unexpected uterine sarcoma following surgery for presumed benign leiomyoma. Oncologist 2015;20:433-9. |
Observational-Tx |
2,075 patients that had undergone myomectomy |
To add precision to the risk assessment of uterine sarcoma in the setting of surgery for presumed benign leiomyoma and to add age stratification to our risk assessment. |
Of 2,075 patients in our retrospective cohort, 6 were diagnosed with uterine sarcoma. Our meta-analysis revealed 8 studies from 1980 to 2014. Combined with our study, 18 cases of leiomyosarcoma are reported in 10,120 patients, for an aggregate risk of 1.78 per 1,000 (95% confidence interval [CI]: 1.1-2.8) or 1 in 562. Eight cases of other uterine sarcomas were reported in 6,889 patients, for an aggregate risk of 1.16 per 1,000 (95% CI: 0.5-4.9) or 1 in 861. The summation of these risks gives an overall risk of uterine sarcoma of 2.94 per 1,000 (95% CI: 1.8-4.1) or 1 in 340. After stratification by age, we predict the risk of uterine sarcoma to range from a peak of 10.1 cases per 1,000, or 1 in 98, for patients aged 75-79 years to <1 case per 500 for patients aged <30 years. |
3 |
| 76. Ulin M, Ali M, Chaudhry ZT, Al-Hendy A, Yang Q. Uterine fibroids in menopause and perimenopause. [Review]. Menopause. 27(2):238-242, 2020 02. |
Review/Other-Tx |
N/A |
To discuss the importance of uterine fibroid pathogenesis and proper treatment plans to be implemented if necessary. |
No results in abstract. |
4 |
| 77. Palomba S, Zupi E, Russo T, et al. A multicenter randomized, controlled study comparing laparoscopic versus minilaparotomic myomectomy: short-term outcomes. Fertil Steril 2007;88:942-51. |
Observational-Tx |
Laparoscopy, n=68 and Minilaparotomy, n=68 |
To compare the laparoscopic and minilaparotomic approaches for symptomatic uterine leiomyomas treatment in terms of safety and feasibility. |
Leiomyoma enucleation and hysterotomy suturing times were significantly shorter after minilaparotomic myomectomy, whereas the degree of surgical difficulty was significantly higher for the laparoscopic myomectomy. Intraoperative blood loss, variation in hemoglobin levels, quantity of pain control drugs used postoperatively, and hospitalization were significantly lower in the laparoscopic group than in the minilaparotomic one. Our surgical outcomes were significantly influenced by specific investigational centers involved, and by leiomyoma dimensions and localizations. This last variable is the strongest predictor of surgical outcome. |
1 |
| 78. Seracchioli R, Rossi S, Govoni F, et al. Fertility and obstetric outcome after laparoscopic myomectomy of large myomata: a randomized comparison with abdominal myomectomy. Hum Reprod 2000;15:2663-8. |
Observational-Tx |
Laparotomy patients (n = 65) and laparoscopy patients (n = 66) |
To compare, in infertile patients, the efficacy of laparoscopic myomectomy versus abdominal myomectomy, in restoring fertility and to evaluate the obstetric outcomes. |
The two groups were homogeneous for number, size and position of large myomata. Significant differences were found in the post-operative outcome: febrile morbidity (> 38 degrees C) was more frequent in the abdominal than in the laparoscopic group (26.2 versus 12.1%; P < 0.05). Laparotomy caused a more pronounced haemoglobin drop (2.17 +/- 1.57 versus 1.33 +/- 1.23; P < 0.001); three patients received a blood transfusion after laparotomy and none after laparoscopy. The post-operative hospital stay was shorter in the laparoscopic group (142.80 +/- 34.60 versus 75.61 +/- 37.09 h; P < 0.001). No significant differences were found between the two groups as concerns pregnancy rate (55.9% after laparotomy, 53.6% after laparoscopy), abortion rate (12.1 versus 20%), preterm delivery (7.4 versus 5%) and the use of Caesarean section (77.8 versus 65%). No case of uterine rupture during pregnancy or labour was observed. |
2 |
| 79. Morgante G, Centini G, Troia L, Orvieto R, De Leo V. Ulipristal acetate before in vitro fertilization: efficacy in infertile women with submucous fibroids. Reprod Biol Endocrinol. 18(1):50, 2020 May 19. |
Experimental-Tx |
27 patients (Fibroids group) and 54 patients (Control group) |
To assess the role of Ulipristal acetate (UPA), a selective progesterone receptor modulator, in restoring uterine cavity deformation due to submucous fibroids, in infertile patients attempting an IVF treatment. To evaluate the impact of preconception UPA treatment on rate of biochemical pregnancy, ongoing pregnancy, and live birth compared to a control group without fibroids. |
Twenty-six patients underwent UPA treatment revealed a mean volume reduction of their fibroids of 41%. A total of 15 (57.6%) biochemical pregnancy were obtained, resulting in 13 (50%) ongoing pregnancy and 9 (34.6%) healthy babies were already delivered. Similar results were obtained in control group. |
1 |
| 80. Hanstede MM, Tempany CM, Stewart EA. Focused ultrasound surgery of intramural leiomyomas may facilitate fertility: a case report. Fertil Steril 2007;88:497 e5-7. |
Review/Other-Tx |
40-year-old woman with known leiomyomas and a history of secondary infertility |
To describe a successful pregnancy after a change in configuration of the endometrial cavity after magnetic resonance imaging-guided focused ultrasound surgery (MRgFUS) for leiomyomas. |
A viable intrauterine pregnancy, with full-term uneventful labor and vaginal delivery. |
4 |
| 81. Zaher S, Lyons D, Regan L. Uncomplicated term vaginal delivery following magnetic resonance-guided focused ultrasound surgery for uterine fibroids. Biomed Imaging Interv J 2010;6:e28. |
Review/Other-Tx |
One 35 year-old patient |
To examine a 35 year-old para 1+0 underwent MRgFUS per study protocol for multiple uterine fibroids. |
She conceived 10 months following the procedure. The patient was induced at 41+6 weeks and underwent a normal vaginal delivery. |
4 |
| 82. Bouwsma EV, Gorny KR, Hesley GK, Jensen JR, Peterson LG, Stewart EA. Magnetic resonance-guided focused ultrasound surgery for leiomyoma-associated infertility. Fertil Steril 2011;96:e9-e12. |
Review/Other-Tx |
One 37-year-old woman with known leiomyomas and a history of 18 months of home-inseminations from a known donor |
To describe magnetic resonance-guided focused ultrasound surgery (FUS) as a treatment for a case of leiomyoma-associated infertility. |
A viable intrauterine pregnancy, with a full-term vaginal delivery, was conceived after a single clomiphene citrate and intrauterine insemination cycle. |
4 |
