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A debate among gynecologic and reproductive surgeons is whether or not there is a clinical need to treat all intramural myomas. Considerations include myoma size and number, ability to access them, whether or not they compromise the endometrium, and treatment effect on gynecologic, reproductive, and obstetric outcomes. We conducted a detailed study regarding intramural myomas, their prevalence in subject populations, the imaging methods used to detect them, their growth rate, their suspected adverse effects on gynecologic, fertility, and obstetric outcomes, and the effectiveness of various treatment methods. The growing body of evidence reported in the literature supports the need to manage intramural myomas and to treat them appropriately.

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OBJECTIVE: To compare 24-month patient-reported outcomes following laparoscopic radiofrequency volumetric thermal ablation (RFVTA) and laparoscopic myomectomy in patients with uterine fibroids. METHOD: An interim analysis of 24-month follow-up data from a randomized controlled trial was performed at Tübingen University Women's Hospital between November 1, 2012 and May 30, 2015. Premenopausal patients, at least 18years of age, who were menstruating, were randomly assigned to be treated for symptomatic uterine fibroids with either RFVTA or laparoscopic myomectomy. The outcomes included in the present per-protocol analysis were patients' responses to validated questionnaires and long-term safety. RESULTS: The study enrolled 51 patients; 21 and 22 patients in the RFVTA and laparoscopic myomectomy groups, respectively, completed 24months of follow-up. Improvements in the severity of symptoms from baseline were reported by participants in both the RFVTA (P<0.001) and laparoscopic myomectomy groups (P=0.001). A significant improvement in health-related quality of life was observed in the laparoscopic myomectomy group (P=0.040); a non-significant improvement was recorded in the RFVTA group (P=0.083). A trocar-site hematoma occurred in one patient in the laparoscopic myomectomy group. Further surgical interventions were recorded in three patients in the RFVTA group but these were unrelated to fibroid symptoms. CONCLUSIONS: These 24-month data suggest equivalence in safety and patient-reported efficacy of RFVTA and laparoscopic myomectomy. ClinicalTrials.gov:NCT01750008.

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Aims: Laparoscopic myomectomy (LM) has been the gold standard treatment for uterine fibroids in women desiring uterine conservation. To evaluate a new fibroid treatment modality - radiofrequency volumetric thermal ablation (RFVTA) - we compare 12-month results in women who had symptomatic uterine fibroids and who were randomized to laparoscopic ultrasound-guided RFVTA or LM. Materials and Methods: Our study is a 1 : 1 parallel, randomized, prospective, single-center, longitudinal, comparative analysis of RFVTA to LM for fibroid treatment in women ≥ 18 years of age who desired uterine conservation. Fifty women were randomized intraoperatively to RFVTA (n = 25) or to LM (n = 25) after laparoscopic ultrasound mapping of the uterus. Results: Post surgery, ablation and myomectomy subjects took pain medications for 4 days (range: 1-46) and 7 days (range: 1-83 days) respectively (p = 0.60). Ablation and myomectomy subjects missed 10.0 workdays (range: 2-86 days) and 17.0 workdays (range: 7-30 days) (p = 0.28), resumed normal activities in 20.5 days (range: 5-103 days) versus 28.0 days (range: 10-42 days) (p = 0.86) respectively. Mean symptom severity scores decreased (improved) by - 7.8 for the ablation subjects and by - 17.9 for the myomectomy subjects (p = 0.16). Health-related quality of life improved (increased) by 7.5 and 13.1, respectively, for the two groups (p = 0.46). Two myomectomy subjects had pregnancies that ended in a Cesarean delivery and a vaginal delivery of healthy infants. Two pregnancies in the RFVTA group ended in full-term vaginal deliveries of healthy infants. Conclusions: Early postoperative recovery and twelve-month results attest to similar clinical benefits from RFVTA and LM.

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In addition to surgical methods of treating uterine fibroids, numerous non-invasive treatments have been developed. Many of these involve the use of hyperthermia, the heating of tissue by a variety of methods. These include the use of lasers, radiofrequency, microwave energy and high intensity focused ultrasound, guided by both ultrasound and magnetic resonance imaging. In this review we examine the technology behind these treatment modalities and review the current evidence for their use.

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OBJECTIVE: To compare the mean hospital discharge times and perioperative outcomes for radiofrequency volumetric thermal ablation (RFVTA) of fibroids and laparoscopic myomectomy (LM). METHODS: The present postmarket, randomized, prospective, single-center, longitudinal, comparative study, conducted in Tübingen, Germany, evaluated the outcomes of RFVTA and the current standard of care (LM) for symptomatic uterine fibroids in women who desired uterine conservation. The surgeons were blinded to the treatment until all fibroids had been mapped by laparoscopic ultrasound. RESULTS: The mean hospitalization times were 10.0 ± 5.5 (median 7.8 [range 4.2-25.5]) hours for the RFVTA group and 29.9 ± 14.2 (median 22.6 [range 16.1-68.1]) hours for the LM group (P < 0.001, Wilcoxon test). Intraoperative blood loss was 16 ± 9 (median 20 [range: 0-30]) mL for the RFVTA procedures and 51 ± 57 (median 35 [range 10-300]) mL for the LM procedures. The percentage of fibroids imaged by laparoscopic ultrasound that were treated/excised was 98.6% for RFVTA and 80.3% for LM. Two complications were reported: vertigo (n = 1; RFVTA) and port site hematoma (n = 1; LM). CONCLUSION: Radiofrequency volumetric thermal ablation resulted in the treatment of more fibroids, a significantly shorter hospital stay, and less intraoperative blood loss than laparoscopic myomectomy. ClinicalTrials.gov:NCT01750008.

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STUDY OBJECTIVE: To analyze the clinical success of radiofrequency volumetric thermal ablation (RFVTA) at 3-year follow-up in terms of subject responses to validated questionnaires and surgical repeat intervention to treat myomas. DESIGN: Prospective follow-up of patients for 36 months after treatment in a multicenter international trial of outpatient, laparoscopic ultrasound-guided RFVTA of symptomatic uterine myomas (Canadian Task Force classification II-1). SETTING: University hospitals and private surgical centers. PATIENTS: One hundred thirty-five premenopausal women (mean [SD] age, 42.5 [4.6] years; body mass index, 30.5 [6.1]) with symptomatic uterine myomas and objectively confirmed heavy menstrual bleeding (≥ 160 to ≤ 500 mL). INTERVENTIONS: Laparoscopic ultrasound-guided RFVTA. MEASUREMENTS AND MAIN RESULTS: One hundred four participants were followed prospectively for 36 months after treatment of myomas via RFVTA. For 104 evaluable participants with 36-month data, change in mean (SD) symptom severity from baseline (60.2 [18.8]) to 36 months was -32.6 (95% confidence interval, -37.5 to -27.8; p < .001). Health-related quality of life also was improved, from the baseline value of 39.2 (19.2) to 38.6 (95% confidence interval, 33.3 to 43.9; p < .001) at 36 months. Patient-reported Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire subscores demonstrated statistically significant improvement from baseline to 36 months in all categories (Concern, Activities, Energy/Mood, Control, Self-consciousness, and Sexual Function) (p < .001). For the 104 participants with 36-month data, mean state of health scores (EuroQOL-5D Health State Index) improved from a baseline value of 71.0 (19.3) to 86.2 (11.7) at 36 months. The cumulative repeat intervention rate of 11% (14 of 135 participants) at 36 months was well below the possible 25% maximum expected at the beginning of the trial. CONCLUSION: RFVTA of uterine myomas resulted in sustained relief from myoma symptoms and continued improvement in health-related quality of life through 36 months after ablation. The low repeat intervention data through 36 months is a positive outcome for patient well-being.

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STUDY OBJECTIVE: To determine the efficacy of laparoscopic ultrasound (LUS) as compared with contrast-enhanced magnetic resonance imaging (CE-MRI) and transvaginal ultrasound (TVUS) in detection of uterine myomas. DESIGN: Retrospective study of imaging methods used in a trial of LUS-guided radiofrequency volumetric thermal ablation in women with symptomatic myomas (Canadian Task Force classification II-2). SETTING: Eleven medical university or private outpatient surgery clinics in the United States (nine sites) and Latin America (two sites). PATIENTS: One hundred thirty-five women with symptomatic myomas and objectively confirmed moderate to severe heavy menstrual bleeding. INTERVENTIONS: LUS-guided radiofrequency volumetric thermal ablation of myomas. MEASUREMENTS AND MAIN RESULTS: Preoperative TVUS scans and CE-MRIs were read at each site, and all CE-MRIs were read by a central reader. LUS-guided scans were obtained intraoperatively by each surgeon by mapping the uterus just before radiofrequency volumetric thermal ablation. The imaging methods and their yields in terms of number of myomas found per subject were as follows: TVUS, 403 myomas (mean [SD] 3 [1.8]; range, 1-8); site CE-MRI, 562 myomas (4.2 [3.8]; range, 1-18); central reader, 619 myomas (4.6 [3.7]; range, 0-20); and LUS, 818 myomas (6.1 [4.9]; range, 1-29) (p < .001). LUS was superior to TVUS, CE-MRI, and the central reader for detection of small (≤1 cm(3)) myomas. Most imaged myomas were intramural: 197 (50.9%) by TVUS, 298 (55.5%) by site CE-MRI, 290 (48.7%) by the central reader, and 386 (48.5%) by LUS. CONCLUSION: Compared with CE-MRI and TVUS, LUS demonstrates the most myomas, regardless of size or type.

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STUDY OBJECTIVE: To evaluate the effect of radiofrequency volumetric thermal ablation (RFVTA) on menstrual bleeding in patients with intramural myomas. DESIGN: Retrospective analysis of a recently completed prospective trial of laparoscopic ultrasound-guided RFVTA in which 135 subjects had objectively measured heavy menstrual bleeding (≥160 to ≤500 mL) and confirmed submucosal, intramural, and subserosal myomas. We analyzed the pretreatment monthly menstrual blood loss as well as the response to treatment based on the types of myomas, specifically those subjects with only intramural myomas versus those with only submucosal myomas or those with both (Canadian Task Force classification II-2). SETTING: Outpatient hospital and private surgery centers. PATIENTS: One hundred thirty-five premenopausal symptomatic women (mean age: 42.4 ± 4.5 years) with uterine myomas and heavy menstrual bleeding confirmed by alkaline hematin analysis. INTERVENTIONS: Laparoscopic ultrasound-guided RFVTA. MEASUREMENTS AND MAIN RESULTS: Menstrual blood loss (MBL) at baseline and at 12 months after the procedure was quantified in 122 subjects with intramural myomas (including those that abut the endometrium, those that are within the myometrium, and those that extend from the serosa into the myometrium) and/or submucous myomas. Although 91.8% (112/122) of these subjects had 1 or more intramural myomas, submucous myomas were present in fewer than half of the subjects ([48.4%]). We identified 10 subjects who had submucous but no intramural myomas. This group had a significant (-45.1%) posttreatment decrease in monthly bleeding (95% confidence interval [CI], -78.0% to -12.2%; p = .013). In this same study, there were 63 subjects with intramural myomas and no submucosal myomas, and their posttreatment decrease in MBL of -31.8% was also clinically and statistically significant (95% CI, -41.4% to -22.2%; p<.001). Of those 63 subjects was a subset with intramural myomas (n = 27) without myomas abutting the endometrium or submucous myomas; this third set also resulted in a clinically and statistically significant reduction in MBL (-25.0% and -65.22 mL; 95% CI, -38.8% to -11.2%; p = .001). CONCLUSION: Although it has been known that the treatment of submucous myomas results in a reduction of MBL, this is the first study to show that radiofrequency ablative therapy for intramural myomas without a submucosal component will also result in a significant reduction in menstrual blood loss.

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