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.

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. 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. 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. 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.

Comparison of Levonorgestrel-releasing Intrauterine System (LNG-IUS) against Laparoscopic Assisted Supracervical Hysterectomy (LASH) for menorrhagia treatment: An economic evaluation.

BACKGROUND: This economic evaluation and literature review was conducted with the primary aim to compare the cost-effectiveness of laparoscopic assisted supracervical hysterectomy (LASH) with NICE's gold-standard treatment of Levonorgestrel-releasing intrauterine system (LNG-IUS) for menorrhagia. MATERIALS AND METHODS: A cost-utility analysis was conducted from an NHS perspective, using data from two European studies to compare the treatments. Individual costs and benefits were assessed within one year of having the intervention. An Incremental Cost-Effectiveness Ratio (ICER) was calculated, followed by sensitivity analysis. Expected Quality Adjusted Life Years (QALYS) and costs to the NHS were calculated alongside health net benefits (HNB) and monetary net benefits (MNB). RESULTS: A QALY gain of 0.069 was seen in use of LNG-IUS compared to LASH. This yielded a MNB between -£44.99 and -£734.99, alongside a HNB between -0.0705 QALYs and -0.106 QALYS. Using a £20,000-£30,000/QALY limit outlined by NICE,this showed the LNG-IUS to be more cost-effective than LASH, with LASH exceeding the upper bound of the £30,000/QALY limit. Sensitivity analysis lowered the ICER below the given threshold. CONCLUSIONS: The ICER demonstrates it would not be cost-effective to replace the current gold-standard LNG-IUS with LASH, when treating menorrhagia in the UK. The ICER's proximity to the threshold and its high sensitivity alludes to the necessity for further research to generate a more reliable cost-effectiveness estimate. However, LASH could be considered as a first line treatment option in women with no desire to have children.

Keyhole hysterectomy is effective for women with heavy menstrual bleeding.

The studyCooper K, Breeman S, Scott NW, et al. Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH): a parallel-group, open-label, randomised controlled trial. Lancet 2019;394:1425-36.The study was funded by the NIHR Health Technology Assessment Programme (project number 12/35/23).To read the full NIHR Signal, go to: https://discover.dc.nihr.ac.uk/content/signal-000837/keyhole-hysterectomy-is-effective-for-women-with-heavy-menstrual-bleeding.

Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH): a parallel-group, open-label, randomised controlled trial.

BACKGROUND: Heavy menstrual bleeding affects 25% of women in the UK, many of whom require surgery to treat it. Hysterectomy is effective but has more complications than endometrial ablation, which is less invasive but ultimately leads to hysterectomy in 20% of women. We compared laparoscopic supracervical hysterectomy with endometrial ablation in women seeking surgical treatment for heavy menstrual bleeding. METHODS: In this parallel-group, multicentre, open-label, randomised controlled trial in 31 hospitals in the UK, women younger than 50 years who were referred to a gynaecologist for surgical treatment of heavy menstrual bleeding and who were eligible for endometrial ablation were randomly allocated (1:1) to either laparoscopic supracervical hysterectomy or second generation endometrial ablation. Women were randomly assigned by either an interactive voice response telephone system or an internet-based application with a minimisation algorithm based on centre and age group (<40 years vs ≥40 years). Laparoscopic supracervical hysterectomy involves laparoscopic (keyhole) surgery to remove the upper part of the uterus (the body) containing the endometrium. Endometrial ablation aims to treat heavy menstrual bleeding by destroying the endometrium, which is responsible for heavy periods. The co-primary clinical outcomes were patient satisfaction and condition-specific quality of life, measured with the menorrhagia multi-attribute quality of life scale (MMAS), assessed at 15 months after randomisation. Our analysis was based on the intention-to-treat principle. The trial was registered with the ISRCTN registry, number ISRCTN49013893. FINDINGS: Between May 21, 2014, and March 28, 2017, we enrolled and randomly assigned 660 women (330 in each group). 616 (93%) of 660 women were operated on within the study period, 588 (95%) of whom received the allocated procedure and 28 (5%) of whom had an alternative surgery. At 15 months after randomisation, more women allocated to laparoscopic supracervical hysterectomy were satisfied with their operation compared with those in the endometrial ablation group (270 [97%] of 278 women vs 244 [87%] of 280 women; adjusted percentage difference 9·8, 95% CI 5·1-14·5; adjusted odds ratio [OR] 2·53, 95% CI 1·83-3·48; p<0·0001). Women randomly assigned to laparoscopic supracervical hysterectomy were also more likely to have the best possible MMAS score of 100 than women assigned to endometrial ablation (180 [69%] of 262 women vs 146 [54%] of 268 women; adjusted percentage difference 13·3, 95% CI 3·8-22·8; adjusted OR 1·87, 95% CI 1·31-2·67; p=0·00058). 14 (5%) of 309 women in the laparoscopic supracervical hysterectomy group and 11 (4%) of 307 women in the endometrial ablation group had at least one serious adverse event (adjusted OR 1·30, 95% CI 0·56-3·02; p=0·54). INTERPRETATION: Laparoscopic supracervical hysterectomy is superior to endometrial ablation in terms of clinical effectiveness and has a similar proportion of complications, but takes longer to perform and is associated with a longer recovery. FUNDING: UK National Institute for Health Research Health Technology Assessment Programme.

The case against endometrial ablation for treatment of heavy menstrual bleeding.

PURPOSE OF REVIEW: Endometrial ablation is a common treatment for heavy menstrual bleeding, but serious limitations and long-term complications exist. Our purpose is to summarize the use of endometrial ablation devices, potential short-term and long-term complications, cost effectiveness, and quality of life in relation to alternative treatments. RECENT FINDINGS: There is insufficient evidence to strongly recommend one endometrial ablation device over another. Providers should consider and discuss with their patients, complications including risk of future pregnancy, endometrial cancer, and hysterectomy for continued bleeding or pain. Patient selection is key to reducing postablation pain and failure; patients with a history of tubal ligation and dysmenorrhea should consider alternative treatments. All patients should also be counseled that the levonorgestrel intrauterine device is a cost-effective alternative with higher quality of life and fewer complications. Hysterectomy is definitive treatment with higher quality of life and fewer complications. SUMMARY: Although endometrial ablation can offer adequate symptom control for patients who have failed medical therapy, desire uterine preservation, or who are high-risk surgical candidates, patients should be appropriately selected and counseled regarding the potential for treatment failure and long-term complications.

Endometrial resection and global ablation in the normal uterus.

There are various methods that can be used to destroy the endometrium as a treatment for menorrhagia. This chapter reviews the history, rationale, evidence, indications and long-term safety and efficacy of the current techniques. It also discusses endometrial ablation in the context of its clinical utility in comparison with existing alternative treatments.

Comparison of the levonorgestrel-releasing intrauterine system, hysterectomy, and endometrial ablation for heavy menstrual bleeding in a decision analysis model.

BACKGROUND: A better understanding of the relative risks and benefits of common treatment options for abnormal uterine bleeding (AUB) can help providers and patients to make balanced, evidence-based decisions. OBJECTIVES: To provide comparative estimates of clinical outcomes after placement of levonorgestrel-releasing intrauterine system (LNG-IUS), ablation, or hysterectomy for AUB. SEARCH STRATEGY: A PubMED search was done using combinations of search terms related to abnormal uterine bleeding, LNG-IUS, hysterectomy, endometrial ablation, cost-benefit analysis, cost-effectiveness, and quality-adjusted life years. SELECTION CRITERIA: Full articles published in 2006-2016 available in English comparing at least two treatment modalities of interest among women of reproductive age with AUB were included. DATA COLLECTION AND ANALYSIS: A decision tree was generated to compare clinical outcomes in a hypothetical cohort of 100 000 premenopausal women with nonmalignant AUB. We evaluated complications, mortality, and treatment outcomes over a 5-year period, calculated cumulative quality-adjusted life years (QALYs), and conducted probabilistic sensitivity analysis. MAIN RESULTS: Levonorgestrel-releasing intrauterine system had the highest number of QALYs (406 920), followed by hysterectomy (403 466), non-resectoscopic ablation (399 244), and resectoscopic ablation (395 827). Ablation had more treatment failures and complications than LNG-IUS and hysterectomy. Findings were robust in probabilistic sensitivity analysis. CONCLUSIONS: Levonorgestrel-releasing intrauterine system and hysterectomy outperformed endometrial ablation for treatment of AUB.

Evaluation of quality of life and cost-effectiveness of definitive surgery and the levonorgestrel intrauterine system as treatment options for heavy menstrual bleeding.

BACKGROUND/AIM: This study aimed to compare the levonorgestrel intrauterine system (LNG-IUS) with abdominal hysterectomy (TAH) and total laparoscopic hysterectomy (TLH) as first-line treatments for heavy menstrual bleeding (HMB). MATERIALS AND METHODS: Ninety-eight patients aged 20-55 years who complained of regular heavy menstrual bleeding were enrolled in the study. The TAH group included 29 patients, the LNG-IUS group included 34, and the TLH group included 35. These groups were compared in terms of quality of life and the cost-effectiveness of the selected methods. Quality of life was assessed using the 36-Item Short Form (SF-36), and cost-effectiveness was assessed according to the current cost of each approach. RESULTS: The quality of life parameters, with the exception of mental health, improved significantly in the LNG-IUS, TAH, and TLH groups. The mean costs of the LNG-IUS, TAH, and TLH procedures were $99.15 ± 4.90, $538.82 ± 193.00 and $1617.05 ± 258.44, respectively (P < 0.05). Overall, LNG-IUS was the most cost-effective treatment option. CONCLUSION: The outcome measures of the SF-36 revealed that after 6 months, these treatments were equal in terms of quality of life, except for mental health. LNG-IUS was the most cost-effective approach.

Is the Pictorial Blood Loss Assessment Chart (PBAC) score associated with treatment outcome after endometrial ablation for heavy menstrual bleeding? A cohort study.

OBJECTIVE: The Pictorial Blood Loss Assessment Chart (PBAC) is a validated tool that is used to diagnose heavy menstrual bleeding (HMB). Knowledge of the effect of its score and its relationship with outcome could have implications for using the PBAC as an outcome measurement in future HMB studies, and as a tool to evaluate the treatment effect in research and clinical practice. Our aim was to relate PBAC scores to other measures of success after endometrial ablation for HMB. DESIGN: Analysis of individual patient data (IPD) of randomised controlled trials studying women with HMB. SETTING: Women with HMB consulting their gynecologists. POPULATION OR SAMPLE: Individual patient data (IPD) of randomised controlled trials studying women with HMB. METHODS: We included studies if they had studied second-generation endometrial ablation techniques and had collected PBAC scores for both baseline and follow-up. The effectiveness of treatment was scored as satisfaction or re-intervention (yes/no) 12 months after treatment. We related these outcomes to the PBAC score at 12 months after treatment, and to PBAC decrease between baseline and 12 months of follow-up. RESULTS: We studied data for 900 patients included in nine studies. The median PBAC score at 12 months was 7 (0-2500). The overall satisfaction rate was 89% and the overall re-intervention rate was 7.2%. A clear association was found between absolute PBAC score at the 12-month follow-up and satisfaction (odds ratio, OR 0.16; 95% confidence interval, 95% CI 0.11-0.24) and surgical re-intervention (OR 2.3, 95% CI 1.8-2.8). A change in PBAC score was also associated with satisfaction (OR 2.0, 95% CI 1.7-2.3) and surgical re-intervention (OR 0.69, 95% CI 0.63-0.75). Both the absolute PBAC scores and the changes in score show high accuracy for both treatment outcomes. CONCLUSIONS: PBAC scores at 12 months after treatment are significantly associated with satisfaction and re-intervention rates. We propose to use the PBAC in research as a primary end point in studies on HMB, and in clinical practice as a measure to assess the effectiveness of treatment. TWEETABLE ABSTRACT: PBAC scores 12 months after treatment are significantly associated with satisfaction and reintervention rates.

Levonorgestrel-Releasing Intrauterine System (52 mg) for Idiopathic Heavy Menstrual Bleeding: A Health Technology Assessment.

BACKGROUND: Heavy menstrual bleeding affects as many as one in three women and has negative physical, economic, and psychosocial impacts including activity limitations and reduced quality of life. The goal of treatment is to make menstruation manageable, and options include medical therapy or surgery such as endometrial ablation or hysterectomy. This review examined the evidence of effectiveness and cost-effectiveness of the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) as a treatment alternative for idiopathic heavy menstrual bleeding. METHODS: We conducted a systematic review of the clinical and economic evidence comparing LNG-IUS with usual medical therapy, endometrial ablation, or hysterectomy. Medline, EMBASE, Cochrane, and the Centres for Reviews and Dissemination were searched from inception to August 2015. The quality of the evidence was assessed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We also completed an economic evaluation to determine the cost-effectiveness and budget impact of the LNG-IUS compared with endometrial ablation and with hysterectomy. The economic evaluation was conducted from the perspective the Ontario Ministry of Health and Long-Term Care. RESULTS: Relevant systematic reviews (n = 18) returned from the literature search were used to identify eligible randomized controlled trials, and 16 trials were included. The LNG-IUS improved quality of life and reduced menstrual blood loss better than usual medical therapy. There was no evidence of a significant difference in these outcomes compared with the improvements offered by endometrial ablation or hysterectomy. Mild hormonal side effects were the most commonly reported. The quality of the evidence varied from very low to moderate across outcomes. Results from the economic evaluation showed the LNG-IUS was less costly (incremental saving of $372 per person) and more effective providing higher quality-adjusted life years (incremental value of 0.05) compared with endometrial ablation. Similarly, the LNG-IUS costs less (incremental saving of $3,138 per person) and yields higher quality-adjusted life-years (incremental value of 0.04) compared with hysterectomy. Publicly funding LNG-IUS as an alternative to endometrial ablation and hysterectomy would result in annual cost savings of $3 million to $9 million and $0.1 million to $23 million, respectively, over the first 5 years. CONCLUSIONS: The 52-mg LNG-IUS is an effective and cost-effective treatment option for idiopathic heavy menstrual bleeding. It improves quality of life and menstrual blood loss, and is well tolerated compared with endometrial ablation, hysterectomy, or usual medical therapies.

Economic and clinical benefits of radiofrequency ablation versus hysterectomy in patients suffering from menorrhagia: a retrospective analysis with German health claims data.

OBJECTIVE: To assess clinical and economic benefits of radiofrequency ablation (RFA) compared to hysterectomy when treating patients suffering from menorrhagia. METHODS: Based on German health claims data, a retrospective, longitudinal, observational analysis was performed. Patients having continuously statutory health insurance coverage during the study and being coded for menorrhagia and a relevant treatment option were included in the analysis. The control group was created using propensity score matching. RESULTS: We discovered that using RFA generates cost savings of €1844 during the quarter of performance. As direct costs during a 2-year follow-up show similar levels in both groups, these initial savings can be preserved. This is partly because even if more patients in the RFA group were re-coded for menorrhagia after initial therapy, just a small proportion of these patients required another surgical intervention. CONCLUSION: RFA should more often be considered a relevant treatment option both from an economic and a medical point of view.

Trends in the national distribution of laparoscopic hysterectomies from 2003 to 2010.

STUDY OBJECTIVE: The purpose of this analysis was to compare the trends in undergoing laparoscopic hysterectomy (versus abdominal or vaginal hysterectomy) based on patient age, race, median income and insurance type, from 2003 to 2010. DESIGN: Retrospective study (Canadian Task Force classification II-3). SETTING: National sample of hospital admissions after hysterectomy. PATIENTS: Health Cost and Utilization Project-Nationwide Inpatient Sample database was used to review records of women who underwent hysterectomy for either menorrhagia or leiomyoma from 2003-2010. INTERVENTION: The predicted probability of undergoing laparoscopic hysterectomy was determined for each year according to patient age, race, median income, and insurance type. The slopes of these values (i.e. the trend) was compared for each subgroup (i.e. black, white, Asian, etc.) in these categories. MAIN RESULTS: A total of 530, 154 cases were included in this study. Total number of hysterectomies decreased by 39% from 60,364 to 36,835 from 2003 to 2010. The percent of hysterectomies that were laparoscopic increased from 11% in 2003 to 29% in 2010. All groups analyzed experienced an increase in predicted probability of undergoing a laparoscopic hysterectomy. Of all women undergoing hysterectomy, the probability of undergoing a laparoscopic hysterectomy remained highest for women who were less than 35 years old, white, with the highest median income, and with private insurance from 2003-2010. The slope was significantly greater for (1) white females versus all other races analyzed (p<0.01), (2) females in the highest income quartile versus females in the lowest income quartile (p<0.01) and (3) females with private insurance versus females with Medicaid (p<0.01) or Medicare (p<0.01). CONCLUSIONS: There remains a gap in distribution of laparoscopic hysterectomies with regards to age, race, median income and insurance type that does not seem to be closing, despite the increased availability of laparoscopic hysterectomies.

Assessment of periodic blood loss: interindividual and intraindividual variations of pictorial blood loss assessment chart registrations.

STUDY OBJECTIVE: To explore the interindividual and intraindividual variation of Pictorial Blood Loss Assessment Chart (PBAC) registrations of subjective perception of minimal, normal, and heavy menstrual bleeding in women using their usual sanitary protection. DESIGN: Retrospective study (Canadian Task Force classification II-3). SETTING: University tertiary hospital. PATIENTS: Women who had participated in 4 previously published prospective studies using PBAC as the outcome measure. INTERVENTIONS: Patients underwent hysteroscopic removal of polyps, laparoscopic occlusion of uterine vessels, or uterine artery embolization, and control subjects received no treatment. MEASUREMENTS AND MAIN RESULTS: PBAC scores, hemoglobin concentration, and subjective assessment of periodic blood loss were recorded in 429 women during 1049 menstrual cycles. The median PBAC values in groups of women who assessed their bleeding as light, normal, and heavy were 45.0, 116.0, and 254.5, respectively (p < .001). Sensitivity and specificity for specific PBAC cutoff points were calculated using a receiver operating characteristic curve. The maximum sensitivity for assessment of heavy periodic blood loss (78.5) was reached at a PBAC score of 160. The corresponding specificity was 75.8. At PBAC values below 130, 90% of the women reported normal blood loss, and 91% had hemoglobin values >12.0 g/dL. The reliability of repeated PBAC scores for individual measures was assessed via calculation of the intraclass correlation coefficient, which for repeated PBAC measurements was 0.86 (95% confidence interval, 0.80-0.90) for average measures. CONCLUSION: The interindividual variation was high, and the intraindividual variation was low. A low PBAC score may be used to define treatment end points for clinical use or in trials.

Cost-effectiveness of hysterectomy for benign gynecological conditions: a systematic review.

The objective of this study was to assess the cost-effectiveness of hysterectomy performed for benign indications. Hysterectomy remains the most common major gynecological operation in the Western world. Rates of hysterectomy have not declined as expected with the introduction of new treatment options. Furthermore, use of laparoscopic techniques varies widely within the Nordic countries. We designed a systematic review in a University Central Hospital. The sample included all published studies regarding the cost-effectiveness of hysterectomy performed for benign indications (n = 1666). Medline, Cochrane Library, PsycINFO, CINAHL, and Nursing databases were searched. Inclusion criteria were the availability of pre- and post-intervention health-related quality of life measures (HRQoL) and data on costs. HRQoL, costs, and cost-effectiveness of treatment were the main outcome measures. Studies (n = 24) focused on treatment of symptomatic fibroids (n = 8), treatment of heavy menstrual bleeding (n = 10), various surgical techniques (n = 5) and the effect of various indications for hysterectomy (n = 2). Follow-up periods varied from 4 months to over 10 years. SF/RAND-36 or EQ-5D measures and societal cost perspective were most commonly used. Only 11 studies used individual patient data. HRQoL following hysterectomy was generally good but costs were high. The cost-effectiveness depended on indication, age, and duration of follow-up. The cost-effectiveness of hysterectomy has been surprisingly poorly studied. Conclusions are difficult to draw due to different study designs, indications, follow-up times, and HRQoL instruments used. Rates of hysterectomy have declined less than expected with the introduction of new treatment modalities. Costs of surgery are high. Laparoscopic hysterectomy seems to be the least cost-effective, although further data from original patient cohorts with long-term follow-up are needed.

Global ablation techniques.

Global endometrial ablation techniques are a relatively new surgical technology for the treatment of heavy menstrual bleeding that can now be used even in an outpatient clinic setting. A comparison of global ablation versus earlier ablation technologies notes no significant differences in success rates and some improvement in patient satisfaction. The advantages of the newer global endometrial ablation systems include less operative time, improved recovery time, and decreased anesthetic risk. Ablation procedures performed in an outpatient surgical or clinic setting provide advantages both of potential cost savings for patients and the health care system and improved patient convenience.

First- versus second-generation endometrial ablation devices for treatment of menorrhagia: a systematic review, meta-analysis and appraisal of economic evaluations.

OBJECTIVE: To estimate the clinical and economic effect of using second-generation endometrial ablation devices compared to first-generation devices for treatment of menorrhagia in pre-menopausal women. The secondary objective was to compare the second-generation devices with one another. DATA SOURCES: We searched Medline and EMBASE, and other sources of unpublished literature, and screened references from relevant articles. STUDY SELECTION: We included only randomized controlled trials or full economic evaluations of premenopausal women with menorrhagia undergoing endometrial ablation using first-generation compared with second-generation devices. DATA EXTRACTION AND DATA SYNTHESIS: Data extraction and risk of bias assessment was carried out for all clinical studies, and data were pooled using the random effects model. A qualitative narrative synthesis was used to combine results from the economic review. Eleven studies met eligibility criteria (n = 1679). There was no difference in the rate of amenorrhea between first- and second-generation ablation (5 studies with 998 patients, rate ratio 1.15, 95% CI 0.96 to 1.38; P = 0.14), but second-generation devices had a lower complication rate (7 studies with 1272 patients, rate ratio 0.52, 95% CI 0.35 to 0.76; P < 0.001), decreased operating time by 16.6 minutes (3 studies with 486 patients, 95% CI 12.1 to 21.2 minutes; P < 0.001), and could more commonly be used with local anaesthesia (3 studies with 558 patients, rate ratio 1.87, 95% CI 1.04 to 3.37; P = 0.04). There was a higher rate of amenorrhea in patients treated with Novasure than with other second-generation devices (4 studies with 407 patients, rate ratio 2.60, 95% CI 1.63 to 4.14; P < 0.001). Three European studies were included in the economic synthesis, which found that second-generation devices were more cost-effective than first-generation devices. CONCLUSION: Second-generation endometrial ablation devices seem to be as effective as first-generation devices but likely reduce operating time, can be used more often with local anaesthesia, and have fewer complications. They also seem to be more cost-effective than first-generation devices, but further economic evaluations need to be carried out in Canada.

Objectif : Estimer les effets cliniques et économiques de l'utilisation de dispositifs d'ablation endométriale de deuxième génération, par comparaison avec l'utilisation de dispositifs de première génération, pour ce qui est de la prise en charge de la ménorragie chez les femmes préménopausées. Nous avions pour objectif secondaire de comparer les dispositifs de deuxième génération les uns aux autres. Sources de données : Nous avons mené des recherches dans Medline, EMBASE et d'autres sources de littérature non publiée; nous avons également analysé les références des articles pertinents. Sélection d'études : Nous n'avons inclus que les essais comparatifs randomisés ou les évaluations économiques exhaustives comparant l'utilisation de dispositifs d'ablation endométriale de deuxième génération à l'utilisation de dispositifs de première génération chez des femmes préménopausées présentant une ménorragie. Extraction et synthèse des données : L'extraction des données et l'évaluation du risque de biais ont été menées pour toutes les études cliniques, et les données ont été regroupées au moyen du modèle à effets aléatoires. Une synthèse descriptive qualitative a été utilisée pour combiner les résultats issus de l'analyse économique. Onze études ont satisfait aux critères d'admissibilité (n = 1 679). Aucune différence n'a été constatée en matière de taux d'aménorrhée entre les dispositifs d'ablation de première et de deuxième génération (5 études comptant 998 patientes, ratio des taux 1,15, IC à 95 %, 0,96 - 1,38; P = 0,14); cependant, les dispositifs de deuxième génération présentaient un taux de complication moindre (7 études comptant 1 272 patientes, ratio des taux 0,52, IC à 95 %, 0,3 5 - 0,76; P < 0,001), une réduction de 16,6 minutes de la durée de l'opération (3 études comptant 486 patientes, IC à 95 %, 12,1 - 21,2 minutes; P < 0,001) et pouvaient plus couramment être utilisés en présence d'une anesthésie locale (3 études comptant 558 patientes, ratio des taux 1,87, IC à 95 %, 1,04 - 3,37; P = 0,04). Les patientes traitées au moyen du dispositif Novasure ont présenté un taux d'aménorrhée plus élevé que les patientes traitées au moyen d'autres dispositifs de deuxième génération (4 études comptant 407 patientes, ratio des taux 2.60, IC à 95 %, 1,63 - 4,14; P < 0,001). Trois études européennes ont été incluses dans la synthèse économique, laquelle a constaté que les dispositifs de deuxième génération étaient plus rentables que les dispositifs de première génération. Conclusion : Bien que les dispositifs d'ablation endométriale de deuxième génération et de première génération semblent présenter une efficacité comparable, les dispositifs de deuxième génération sont susceptibles de réduire la durée de l'opération, peuvent plus souvent être utilisés en présence d'une anesthésie locale et donnent lieu à un moins grand nombre de complications. Ils semblent également être plus rentables que les dispositifs de première génération; toutefois, la tenue d'autres évaluations économiques au Canada s'avère requise.

Quality of life and costs of levonorgestrel-releasing intrauterine system or hysterectomy in the treatment of menorrhagia: a 10-year randomized controlled trial.

OBJECTIVE: Menorrhagia is a common problem impairing the quality of life (QOL) of many women. Both levonorgestrel-releasing intrauterine system (LNG-IUS) and hysterectomy are effective treatment modalities but no long-term comparative studies of QOL and costs exist. The objective of this study was to compare QOL and costs of LNG-IUS or hysterectomy in the treatment of menorrhagia during 10-year follow-up. STUDY DESIGN: A total of 236 women, aged 35-49 years, referred for menorrhagia to 5 university hospitals in Finland were randomly assigned to treatment with LNG-IUS (n = 119) or hysterectomy (n = 117) and were monitored for 10 years. The main outcome measures were health-related QOL (HRQOL), psychosocial well-being, and cost-effectiveness. RESULTS: A total of 221 (94%) women were followed for 10 years. Although 55 (46%) women assigned to the LNG-IUS subsequently underwent hysterectomy, the overall costs in the LNG-IUS group ($3423) were substantially lower than in the hysterectomy group ($4937). Overall, levels of HRQOL and psychosocial well-being improved during first 5 years but diminished between 5 years and 10 years and the improved HRQOL returned close to the baseline level. There were no significant differences between LNG-IUS and hysterectomy groups. CONCLUSION: Both LNG-IUS and hysterectomy improved HRQOL. The improvement was most striking during the first 5 years. Although many women eventually had hysterectomy, LNG-IUS remained cost-effective.

The cost-effectiveness of the levonorgestrel-releasing intrauterine system for the treatment of idiopathic heavy menstrual bleeding in the United States.

OBJECTIVES: Heavy menstrual bleeding negatively impacts the health and quality of life of about 18 million women in the United States. Although some studies have established the clinical effectiveness of heavy menstrual bleeding treatments, few have evaluated their cost-effectiveness. Our objective was to evaluate the cost-effectiveness of the levonorgestrel-releasing intrauterine system (LNG-IUS) compared with other therapies for idiopathic heavy menstrual bleeding. METHODS: We developed a model comparing the clinical and economic outcomes (from a US payer perspective) of three broad initial treatment strategies over 5 years: LNG-IUS, oral agents, or surgery. Up to three nonsurgical treatment lines, followed by up to two surgical lines, were allowed; unintended pregnancy was possible, and women could discontinue any time during nonsurgical treatments. Menstrual blood loss of 80 ml or more per cycle determined treatment failure. RESULTS: Initiating treatment with LNG-IUS resulted in the fewest hysterectomies (6 per 1000 women), the most quality-adjusted life-years (3.78), and the lowest costs ($1137) among all the nonsurgical strategies. Initiating treatment with LNG-IUS was also less costly than surgery, resulted in fewer hysterectomies (vs. 9 per 1000 for ablation) but was associated with fewer quality-adjusted life-years gained per patient (vs. 3.80 and 3.88 for ablation and hysterectomy, respectively). Sensitivity analyses confirmed these results. CONCLUSIONS: LNG-IUS resulted in the lowest treatment costs and the fewest number of hysterectomies performed over 5 years compared with all other initial strategies and resulted in the most quality-adjusted life-years gained among nonsurgical options. Initial treatment with LNG-IUS is the least costly and most effective option for women desiring to preserve their fertility.

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.).

Retrospective analysis of variation in heavy menstrual bleeding treatments by age and underlying cause.

OBJECTIVE: To describe treatment patterns associated with heavy menstrual bleeding (HMB) in US practice. STUDY DESIGN: A retrospective claims-based analysis of organic (ICD-9 codes 218.x, 621.0, 622.7, 219.x, and bleeding disorders) or idiopathic (no underlying condition identified) HMB treatment patterns among newly diagnosed, commercially insured women who were enrolled in a large US health plan. First HMB claim (index date; ICD-9-CM 626.2 and 627.0), second HMB claim within 180 days of index date, and continuous enrollment ≥6 months prior to (pre-index period) and 18 months following (post-index period) index date were required. RESULTS: The database included 13,579 organic and 21,362 idiopathic HMB patients. More organic HMB patients received only one treatment type (64% vs 58%; p < 0.001) or two treatments types (14% vs 11%; p < 0.001) compared to idiopathic HMB patients. During the 18 month post-index period, fewer organic HMB patients had no observed treatment compared to idiopathic HMB patients (21% vs 31%; p < 0.001). The idiopathic cohort had significantly higher rates (p < 0.001) of medication use and endometrial ablation, whereas the organic HMB cohort had a higher rate of hysterectomy (p < 0.001). Women <35 years were more frequently prescribed medical treatments (p ≤ 0.037), while women aged >35 years utilized significantly more surgical approaches (p < 0.001). CONCLUSIONS: Among organic and idiopathic HMB patients, considerable variation was observed in the medications and procedures used to treat HMB. Current treatment pattern awareness may improve HMB management. Future research is needed to understand factors that influence women's treatment choices (including newer medications LNG-IUS and tranexamic acid) and age in relation to child-bearing preference.