Pseudogaps in Underdoped Cuprates

It has become clear in the past several years that the cuprates show many unusual properties, both in the normal and superconducting states, especially in the underdoped region. In particular, gap-like behavior is observed in magnetic properties, c-axis conductivity and photoemission, whereas in-plane transport properties are only slightly affected by the pseudogap. I shall argue that these experimental evidences must be viewed in the context of the physics of a doped Mott insulator and that they support the notion of spin charge separation. I shall review recent theoretical developments, concentrating on studies based on the t-J model. I shall describe a model based on quasiparticle excitations, which predicts the doping dependence of T_c and anomalous energy-gap-to-T_c ratios. Finally, I shall outline how the model may be derived from a microscopic formulation of the t-J model. After a brief review of the U(1) formulation, I shall explain some of the difficulties encountered there, and how a new SU(2) formulation can resolve some of the difficulties.Comment: 9 pages, 4 figure

Diagnosis and Management of Endometrial Hyperplasia: A UK National Audit of Adherence to National Guidance 2012-20

BackgroundEndometrial hyperplasia (EH) is a precusor lesion for endometrial cancer (EC), the commonest gynaecological malignancy in high-income countries. EH is a proliferation of glandular tissue, classified as either non-atypical endometrial hyperplasia (NEH) or, if the cytological features are abnormal, atypical endometrial hyperplasia (AEH). The clinical significance of AEH is that patients face both a high risk of having occult EC and a high risk of progression to EC if untreated. Recommendations on the care of women with EH were introduced by United Kingdom–wide guidance (Green-top Guide No. 67, 2016). National adherence to guidance is unknown.We aimed to describe the care of patients with EH; to compare the patterns of care for those with EH with national guidance to identify opportunities for quality improvement; and to compare patterns of care prior to and following the introduction of national guidance to understand its impact.Methods and findingsIn this UK-wide patient-level clinical audit, we included 3,307 women who received a new histological diagnosis of EH through a gynaecology service between 1 January 2012 and 30 June 2020. We described first-line management, management at 2 years, and surgical characteristics prior to and following national guidance for EH using proportions and 95% confidence intervals (CIs) and compared process measures between time periods using multilevel Poisson regression.Of the 3,307 patients, 1,570 had NEH and 1,511 had AEH between 2012 and 2019. An additional 85 patients had NEH and 141 had AEH during 2020. Prior to national guidance, 9% (95% CI [6%, 15%]) received no initial treatment for NEH compared with 3% (95% CI [1%, 5%]) post-guidance; 31% (95% CI [26%, 36%]) and 48% (95% CI [43% 53%]) received an intrauterine progestogen, respectively, in the same periods. The predominant management of women with AEH did not differ, with 68% (95% CI [61%, 74%]) and 67% (95 CI [63%, 71%]) receiving first-line hysterectomy, respectively. By 2 years, follow-up to histological regression without hysterectomy increased from 38% (95% CI [33%, 43%]) to 52% (95% CI [47%, 58%]) for those with NEH (rate ratio (RR) 1.38, 95% CI [1.18, 1.63] p < 0.001). We observed an increase in the use of total laparoscopic hysterectomy among those with AEH (RR 1.26, 95% CI [1.04, 1.52]). In the later period, 37% (95% CI [29%, 44%]) of women initially diagnosed with AEH who underwent a first-line hysterectomy, received an upgraded diagnosis of EC. Study limitations included retrospective data collection from routine clinical documentation and the inability to comprehensively understand the shared decision-making process where care differed from guidance.ConclusionsThe care of patients with EH has changed in accordance with national guidance. More women received first-line medical management of NEH and were followed up to histological regression. The follow-up of those with AEH who do not undergo hysterectomy must be improved, given their very high risk of coexistent cancer and high risk of developing cancer

Levonorgestrel intrauterine system versus medical therapy for menorrhagia

Background - Menorrhagia is a common problem, yet evidence to inform decisions about therapy is limited. In a pragmatic, multicenter, randomized trial, we compared the levonorgestrel-releasing intrauterine system (levonorgestrel-IUS) with usual medical treatment in women with menorrhagia who presented to their primary care providers. Methods - We randomly assigned 571 women with menorrhagia to treatment with levonorgestrel-IUS or usual medical treatment (tranexamic acid, mefenamic acid, combined estrogen–progestogen, or progesterone alone). The primary outcome was the patient-reported score on the Menorrhagia Multi-Attribute Scale (MMAS) (ranging from 0 to 100, with lower scores indicating greater severity), assessed over a 2-year period. Secondary outcomes included general quality-of-life and sexual-activity scores and surgical intervention. Results - MMAS scores improved from baseline to 6 months in both the levonorgestrel-IUS group and the usual-treatment group (mean increase, 32.7 and 21.4 points, respectively; P<0.001 for both comparisons). The improvements were maintained over a 2-year period but were significantly greater in the levonorgestrel-IUS group than in the usual-treatment group (mean between-group difference, 13.4 points; 95% confidence interval, 9.9 to 16.9; P<0.001). Improvements in all MMAS domains (practical difficulties, social life, family life, work and daily routine, psychological well-being, and physical health) were significantly greater in the levonorgestrel-IUS group than in the usual-treatment group, and this was also true for seven of the eight quality-of-life domains. At 2 years, more of the women were still using the levonorgestrel-IUS than were undergoing the usual medical treatment (64% vs. 38%, P<0.001). There were no significant between-group differences in the rates of surgical intervention or sexual-activity scores. There were no significant differences in serious adverse events between groups. Conclusions - In women with menorrhagia who presented to primary care providers, the levonorgestrel-IUS was more effective than usual medical treatment in reducing the effect of heavy menstrual bleeding on quality of life. (Funded by the National Institute of Health Research Health Technology Assessment Programme; ECLIPSE Controlled-Trials.com number, ISRCTN86566246.

Medical treatment for heavy menstrual bleeding in primary care: ten-year data from the ECLIPSE trial

BACKGROUND: Heavy menstrual bleeding (HMB) is a common problem that can significantly affect women’s lives. There is a lack of evidence on long-term outcomes after seeking treatment. AIM: To assess continuation rates of medical treatments and rates of surgery in women 10 years after initial management for HMB in primary care. DESIGN AND SETTING: This was a prospective observational cohort study. METHOD: Women with HMB who participated in the ECLIPSE primary care trial (ISRCTN86566246) completed questionnaires 10 years after randomisation to the levonorgestrel-releasing intrauterine system (LNG-IUS) or other usual medical treatments (oral tranexamic acid, mefenamic acid, combined oestrogen–progestogen; or progesterone alone). Outcomes were rates of surgery, medical treatments, and quality of life using the 36-item Short-Form Health Survey (SF-36) and EuroQoL EQ-5D. RESULTS: The responding cohort of 206 women was demographically and clinically representative of the original trial population. Mean age at baseline was 41.9 years (SD 4.9) and 53.7 years (SD 5.1) at follow-up. Over the 10-year follow-up, 60 of 206 (29.1%) women had surgery (hysterectomy n = 34, 16.5%; endometrial ablation n = 26, 12.6%). Between 5 and 10 years, 89 women (43.2%) ceased all medical treatments and 88 (42.7%) used LNG-IUS alone or in combination with other treatments. Fifty-six women (27.2%) were using LNG-IUS at 10 years. There were improvements over time in quality-of-life scores, with no evidence of differences in these or other outcomes between the two groups. CONCLUSION: Medical treatments for women with HMB can be successfully initiated in primary care, with low rates of surgery and improvement in quality of life observed a decade later

Rates of medical or surgical treatment for women with heavy menstrual bleeding: the ECLIPSE trial 10-year observational follow-up study

Background Heavy menstrual bleeding is a common problem that can significantly affect women’s lives until menopause. There is a lack of evidence on longer-term outcomes after seeking health care and treatment for heavy menstrual bleeding. Objectives To assess the continuation rates of medical treatments and the rates of ablative and surgical interventions among women who had participated in the ECLIPSE trial (ISRCTN86566246) 10 years after initial management for heavy menstrual bleeding in primary care. To explore experiences of heavy menstrual bleeding and influences on treatment for women. Design This was a prospective observational cohort study, with a parallel qualitative study. Setting Primary care. Participants A total of 206 women with heavy menstrual bleeding who had participated in the ECLIPSE trial consented to providing outcome data via a questionnaire approximately 10 years after original randomisation. Their mean age at follow-up was 54 years (standard deviation 5 years). A purposeful sample of 36 women also participated in semistructured qualitative interviews. Interventions The ECLIPSE trial randomised participants to either the levonorgestrel-releasing intrauterine system (52 mg) or the usual medical treatment (oral tranexamic acid, mefenamic acid, combined oestrogen–progestogen or progesterone alone, chosen as clinically appropriate by general practitioners and women). Women could subsequently swap or cease their allocated treatment. Main outcome measures The main outcome measures were rates of ablative and surgical treatments; the rate of continuation of medical treatments; and quality of life using the Short Form questionnaire-36 items and EuroQol-5 Dimensions; women’s experiences of heavy menstrual bleeding; and the influences on their decisions around treatment. Results Over the 10-year follow-up period, 60 out of 206 (29%) women had received a surgical intervention [hysterectomy, n = 34 (17%); endometrial ablation, n = 26 (13%)]. Between 5 and 10 years post trial intervention, 89 women (43%) had ceased all medical treatments and 88 (43%) were using the levonorgestrel-releasing intrauterine system alone or in combination with other oral treatments. More women in the usual medical treatment group had also used the levonorgestrel-releasing intrauterine system than women in the levonorgestrel-releasing intrauterine system group. Fifty-six women (28%) used the levonorgestrel-releasing intrauterine system at 10 years. There was no statistically significant difference in generic quality-of-life scores between the two original trial groups, although small improvements in the majority of domains were seen in both groups across time. Women reported wide-ranging impacts on their quality of life and normalisation of their heavy menstrual bleeding experience as a result of the taboo around menstruation. Women’s treatment decisions and experiences were influenced by the perceived quality of health-care interactions with clinicians and their climacteric status. Limitations Fewer than half of the original 571 participants participated; however, the cohort was clinically and demographically representative of the original trial population. Conclusions Medical treatments for women with heavy menstrual bleeding can be initiated in primary care, with low rates of surgical intervention and improvement in quality of life observed 10 years later. Clinicians should be aware of the considerable challenges that women with heavy menstrual bleeding experience at presentation and subsequently over time, and the importance and value to women of patient-centred communication in this context. Future work Any further evaluation of treatments for heavy menstrual bleeding should include long-term evaluation of outcomes and adherence. Trial registration The original ECLIPSE trial was registered as ISRCTN86566246. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 17. See the NIHR Journals Library website for further project information. Plain language summary What is the problem? Heavy menstrual bleeding is a common problem that can significantly affect women’s lives, yet many women do not seek medical help. Medical treatments, such as tablets and a hormonal coil inserted in the womb, were shown to help women with heavy menstrual bleeding in a previous clinical trial that we conducted, called ECLIPSE. What did we plan to do? In the ECLIPSE trial, women provided information for 5 years after their treatment started. We planned to continue to ask these women about their periods, their symptoms and quality of life, and the treatments that they chose about 10 years after they first joined the trial. We did this using questionnaires and by interviewing women. What did we find? We received questionnaires from 206 out of the 490 women (42%) who had participated in the ECLIPSE trial 10 years earlier. Responders were, on average, 54 years old, and half reported that they had reached the menopause. About 3 in 10 women overall had either received a hysterectomy or undergone destruction of the womb lining. Just over one-quarter of women were using the hormonal coil. Quality of life remained improved and was generally higher than that before treatment. There was no big difference in quality of life or in the numbers of women having surgery between those who first used tablets and those who received the coil. Women described the wide-ranging impact of heavy bleeding on their lives and the taboo around periods. Women’s experience of good or poor communication with their doctors, and thoughts about fertility and menopause, influenced the treatment choices that they made. What does this mean? Women’s quality of life was improved by medical treatments for heavy menstrual bleeding, even as menopause approached, and this shows the importance of these treatments. This research can help doctors and women to make more informed decisions about medical and surgical treatments. Scientific summary Background Heavy menstrual bleeding (HMB) is a common problem that can significantly affect women’s lives until menopause. Despite its high incidence and burden, many women do not seek medical help. The Clinical effectiveness and cost-effectiveness of levonorgestrel releasing intrauterine system in primary care against standard treatment for menorrhagia trial (ECLIPSE) randomised 571 women presenting to primary care with HMB to treatment with the levonorgestrel-releasing intrauterine system (LNG-IUS) or usual medical treatment (oral tranexamic acid, mefenamic acid, combined oral contraceptive pill or progesterone alone). The primary outcome was a patient-reported score of the burden of HMB, which was assessed over a 2-year period. This score improved significantly in both groups across all time points compared with baseline scores. At follow-up after 2 years, women in the LNG-IUS group reported significantly greater improvements than women assigned to the usual medical treatment group. By the 5-year follow-up, this benefit was reduced. There is a lack of evidence on longer-term outcomes, beyond 5 years, after seeking health care and treatment for HMB. Objectives The primary objective of this study was to assess continuation rates of medical treatments, and rates of ablative and surgical interventions, in women 10 years after initial management for HMB in primary care. Additional secondary objectives were to develop a greater understanding of the natural history and treatment of HMB, in particular: an assessment of whether or not initial medical treatment (the LNG-IUS or usual medical treatments) influences women’s trajectories an assessment of quality of life and sexual function experienced, and an evaluation of whether or not these are influenced by initial medical treatment a qualitative exploration of women’s experiences of HMB, and decisions about treatments or surgical interventions, to provide insight into women’s choices and what influences them, over this time period. Design This was a prospective observational cohort study, with a parallel qualitative study. Participants A maximum of 490 women who had participated in the ECLIPSE trial (ISRCTN86566246) were available to be re-approached. Of these women, 206 consented to providing outcome data via a questionnaire approximately 10 years after their original randomisation. A purposeful sample of 36 women, who had a range of ages, social diversity (socioeconomic, ethnicity and educational background), educational backgrounds, treatment experiences and trajectories, also participated in semistructured qualitative interviews. Interventions The allocation method of the ECLIPSE trial interventions and the distribution of the treatments used have been previously reported. The ECLIPSE trial randomised participants to either the LNG-IUS or usual medical treatment [oral tranexamic acid, mefenamic acid, combined oestrogen–progestogen or progesterone alone, chosen as clinically appropriate by general practitioners (GPs) and women]. Women could subsequently swap or cease their allocated treatment. Main outcome measures Data were collected directly from women on the use of treatments for HMB and the surgical interventions of hysterectomy and endometrial ablation as the primary outcomes for this observational study. Changes in treatment or cessation of treatment were also recorded. Generic quality of life was assessed using the Short Form questionnaire-36 items (SF-36), the EuroQol-5 Dimensions (EQ-5D) descriptive system and the EQ-5D visual analogue scale. The Sexual Activity Questionnaire (SAQ) measured the pleasure, discomfort and frequency of sexual activity. The primary outcome measure in the original trial was the patient-reported, condition-specific Menorrhagia Multi-Attribute Scale (MMAS) at 2 years’ follow-up. As expected, few (n = 13) respondents completed the MMAS, so no data are reported for this outcome. All semistructured telephone and face-to-face interviews were conducted by a female researcher. Interviews were audio-recorded and transcribed verbatim. The coding of interview transcripts was aided by the application of NVivo (QSR International, Warrington, UK) software, with the field researcher and a senior researcher each identifying emerging themes from the data and then developing these together. Data generation and thematic analysis were iterative until no new themes emerged, suggesting data saturation. A process of member checking was also undertaken. Results The baseline (prior to randomisation) characteristics of the reconsented responding women and those who were not followed up were very similar. The mean age of the women at follow-up was 53.7 years (standard deviation 5.1 years). Over the 10-year follow-up period, 60 out of 206 (29%) women had received a surgical intervention [hysterectomy, n = 34 (16.5%); endometrial ablation, n = 26 (12.6%)]. Between 5 and 10 years, 89 women (43.2%) had ceased all medical treatments and 88 (42.7%) continued to use the LNG-IUS alone or in combination with other oral treatments. Fifty-six women (28%) were using the LNG-IUS at 10 years [35% (38/110) of women originally allocated to the LNG-IUS and 19% (18/96) of women originally allocated to usual medical treatments]. There were improvements over time in SF-36 scores in both women who were initially allocated to the LNG-IUS and women who were allocated to usual medical treatment, with small and statistically insignificant differences between the two original allocation groups. Changes over time in the EQ-5D scores were very small and, again, no differences were seen between the original allocation groups. There was a clear deterioration in the discomfort domain of the SAQ, with no evidence of a difference between the allocation groups, but no changes were seen in the pleasure domain. In the qualitative study, women reported wide-ranging debilitating impacts on their quality of life. Women had often normalised their HMB experience, reflecting wider societal and generational taboos around menstruation and low awareness that HMB is a treatable problem. Treatment decisions and experience were strongly positively or negatively influenced by the perceived quality of health-care interactions with clinicians. Other key influences on women’s decisions about treatment for HMB over time included considerations in their lives in transition (e.g. changing personal relationships, requirements for contraception or desire for children, and changes in work); the effects of treatment on fertility; their health concerns and knowledge, including that of family and peers; and their views about approaching menopause, or on avoiding premature menopause. Limitations Fewer than half of the original 571 participants contributed, but the cohort was demographically and clinically representative of the original trial population. A large proportion of women had, as expected, stopped having periods, owing to either the menopause or the surgical treatment, meaning that only a small number of women were able to report on the original primary outcome measure. Conclusions The study provides a helpful new indication of the expected proportions of women continuing to use or not use treatments for HMB, or progressing to surgical intervention, and of the significant proportion of women using the LNG-IUS, after a decade. Medical treatments for women with HMB can be initiated in primary care, with low rates of surgical intervention and improvement in quality of life observed 10 years later and with high likelihood of avoiding surgery. Clinicians should be aware of the considerable challenges that women with HMB experience over time, and the importance and value of patient-centred communication about treatment in this context. Future work Any further evaluation of treatments for HMB should include the long-term evaluation of outcomes and adherence. Further qualitative research might investigate the perspectives of health professionals, in particular GPs and nurse practitioners in primary care, alongside gynaecologists, to understand the challenges that they may experience seeing women with HMB and to elicit their perceptions of how care may be enhanced. Trial registration The original ECLIPSE trial was registered as ISRCTN86566246. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 17. See the NIHR Journals Library website for further project information

Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding:long-term randomised pragmatic trial in primary care

Background: Heavy menstrual bleeding (HMB) is a common, chronic problem affecting women and health services. However, long-term evidence on treatment in primary care is lacking. Aim: To assess the effectiveness of commencing the levonorgestrel-releasing intrauterine system (LNG-IUS) or usual medical treatments for women presenting with HMB in general practice. Design and setting: A pragmatic, multicentre, parallel, open-label, long term, randomised controlled trial in 63 primary care practices across the English Midlands. Method: In total, 571 women aged 25–50 years, with HMB were randomised to LNG-IUS or usual medical treatment (tranexamic/mefenamic acid, combined oestrogen–progestogen, or progesterone alone). The primary outcome was the patient reported Menorrhagia Multi-Attribute Scale (MMAS, measuring effect of HMB on practical difficulties, social life, psychological and physical health, and work and family life; scores from 0 to 100). Secondary outcomes included surgical intervention (endometrial ablation/hysterectomy), general quality of life, sexual activity, and safety. Results: At 5 years post-randomisation, 424 (74%) women provided data. While the difference between LNG-IUS and usual treatment groups was not significant (3.9 points; 95% confidence interval = −0.6 to 8.3; P = 0.09), MMAS scores improved significantly in both groups from baseline (mean increase, 44.9 and 43.4 points, respectively; P<0.001 for both comparisons). Rates of surgical intervention were low in both groups (surgery-free survival was 80% and 77%; hazard ratio 0.90; 95% CI = 0.62 to 1.31; P = 0.6). There was no difference in generic quality of life, sexual activity scores, or serious adverse events. Conclusion: Large improvements in symptom relief across both groups show treatment for HMB can be successfully initiated with long-term benefit and with only modest need for surgery

Diagnosis and management of endometrial hyperplasia : a UK national audit of adherence to national guidance 2012–2020

Background: Endometrial hyperplasia (EH) is a precusor lesion for endometrial cancer (EC), the commonest gynaecological malignancy in high-income countries. EH is a proliferation of glandular tissue, classified as either non-atypical endometrial hyperplasia (NEH) or, if the cytological features are abnormal, atypical endometrial hyperplasia (AEH). The clinical significance of AEH is that patients face both a high risk of having occult EC and a high risk of progression to EC if untreated. Recommendations on the care of women with EH were introduced by United Kingdom–wide guidance (Green-top Guide No. 67, 2016). National adherence to guidance is unknown. We aimed to describe the care of patients with EH; to compare the patterns of care for those with EH with national guidance to identify opportunities for quality improvement; and to compare patterns of care prior to and following the introduction of national guidance to understand its impact. Methods and findings: In this UK-wide patient-level clinical audit, we included 3,307 women who received a new histological diagnosis of EH through a gynaecology service between 1 January 2012 and 30 June 2020. We described first-line management, management at 2 years, and surgical characteristics prior to and following national guidance for EH using proportions and 95% confidence intervals (CIs) and compared process measures between time periods using multilevel Poisson regression. Of the 3,307 patients, 1,570 had NEH and 1,511 had AEH between 2012 and 2019. An additional 85 patients had NEH and 141 had AEH during 2020. Prior to national guidance, 9% (95% CI [6%, 15%]) received no initial treatment for NEH compared with 3% (95% CI [1%, 5%]) post-guidance; 31% (95% CI [26%, 36%]) and 48% (95% CI [43% 53%]) received an intrauterine progestogen, respectively, in the same periods. The predominant management of women with AEH did not differ, with 68% (95% CI [61%, 74%]) and 67% (95 CI [63%, 71%]) receiving first-line hysterectomy, respectively. By 2 years, follow-up to histological regression without hysterectomy increased from 38% (95% CI [33%, 43%]) to 52% (95% CI [47%, 58%]) for those with NEH (rate ratio (RR) 1.38, 95% CI [1.18, 1.63] p < 0.001). We observed an increase in the use of total laparoscopic hysterectomy among those with AEH (RR 1.26, 95% CI [1.04, 1.52]). In the later period, 37% (95% CI [29%, 44%]) of women initially diagnosed with AEH who underwent a first-line hysterectomy, received an upgraded diagnosis of EC. Study limitations included retrospective data collection from routine clinical documentation and the inability to comprehensively understand the shared decision-making process where care differed from guidance. Conclusions: The care of patients with EH has changed in accordance with national guidance. More women received first-line medical management of NEH and were followed up to histological regression. The follow-up of those with AEH who do not undergo hysterectomy must be improved, given their very high risk of coexistent cancer and high risk of developing cancer

Transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the VizAblate® System:three- and six-month endpoint results from the FAST-EU study

This was a prospective, longitudinal, multicenter, single-arm controlled trial, using independent core laboratory validation of MRI results, to establish the effectiveness and confirm the safety of the VizAblate® System in the treatment of symptomatic uterine fibroids. The VizAblate System is a transcervical device that ablates fibroids with radiofrequency energy, guided by a built-in intrauterine ultrasound probe. Fifty consecutive women with symptomatic uterine fibroids received treatment with the VizAblate System. Patients had a minimum Menstrual Pictogram score of 120, no desire for fertility, and met additional inclusion and exclusion criteria. The VizAblate System was inserted transcervically and individual fibroids were ablated with radiofrequency energy. An integrated intrauterine ultrasound probe was used for fibroid imaging and targeting. Anesthesia was at the discretion of each investigator. The primary study endpoint was the percentage change in perfused fibroid volume, as assessed by contrast-enhanced MRI at 3 months. Secondary endpoints, reached at 6 months, included safety, percentage reductions in the Menstrual Pictogram (MP) score and the Symptom Severity Score (SSS) subscale of the Uterine Fibroid Symptom-Quality of Life questionnaire (UFS-QOL), along with the rate of surgical reintervention for abnormal uterine bleeding and the mean number of days to return to normal activity. Additional assessments included the Health-Related Quality of Life (HRQOL) subscale of the UFS-QOL, medical reintervention for abnormal uterine bleeding, and procedure times. Fifty patients were treated, representing 92 fibroids. Perfused fibroid volumes were reduced at 3 months by an average of 68.8 ± 27.8 % (P < 0.0001; Wilcoxon signed-rank test). At 6 months, mean MP and SSS scores decreased by 60.8 ± 38.2 and 59.7 ± 30.4 %, respectively; the mean HRQOL score increased by 263 ± 468 %. There were two serious adverse events (overnight admissions for abdominal pain and bradycardia, respectively) and no surgical reinterventions. These 6-month results suggest that the VizAblate System is safe and effective in providing relief of abnormal uterine bleeding associated with fibroids, with appropriate safety and a low reintervention rate