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Objective: To compare health-related quality of life (HRQoL) after bipolar radio frequency ablation and thermal balloon ablation in women with dysfunctional uterine bleeding. Design: Randomized clinical trial. Setting: Teaching hospital. Patient(s): Women suffering from dysfunctional uterine bleeding. Intervention(s): Bipolar radio frequency ablation and thermal balloon ablation. Main outcome measure(s): Patients were asked to complete HRQoL questionnaires at baseline, and at 2 days, 2 weeks, 3 months, 6 months, and 12 months after surgery. The questionnaires contained the medical outcomes study Short-Form 36 (SF-36), the Self-rating Depression Scale, the Rotterdam Symptom Checklist, State-Trait Anxiety Inventory, and a structured clinical history questionnaire. Result(s): Data on HRQoL were available on at least two different time points in 115 of 126 randomized patients. HRQoL improved significantly over time in both groups, except for the domain of general health in the SF-36. None of the dimensions showed a significant difference between both groups, neither was there a significant interaction between time and treatment effect. Conclusion(s): Both methods significantly improved HRQoL in women with dysfunctional uterine bleeding. However, despite better amenorrhea and satisfaction rates after bipolar radio frequency ablation, there was no difference in HRQoL between the two groups. [Copyright &y& Elsevier]

Objective: To investigate patient preferences for endometrial ablation and a levonorgestrel-releasing intrauterine device (IUD) as alternatives to hysterectomy in the treatment of dysfunctional uterine bleeding.Design: Comparative study based on structured interviews.Setting: A large teaching hospital with 500 beds in the Netherlands.Patient(s): Ninety-six patients who were scheduled for endometrial ablation, 25 patients who were scheduled for hysterectomy, and 23 patients who were scheduled for a levonorgestrel-releasing IUD were interviewed. All of the women had dysfunctional uterine bleeding.Intervention(s): Patients were asked to state their most significant complaints and their reasons for choosing a particular treatment. Subsequently, the preference for endometrial ablation and a levonorgestrel-releasing IUD as alternatives to hysterectomy was assessed during a structured interview. Women were informed about the advantages and disadvantages of all three treatment options. Patients rated their preferences according to different hypothetical success rates. The success rates after endometrial ablation and levonorgestrel-releasing IUD were varied until patients found an acceptable treatment outcome.Main outcome measure(s): Patient preference of endometrial ablation and the levonorgestrel-releasing IUD over hysterectomy.Result(s): The main reason for the treatment of choice differed between the three groups. Most of the patients in the hysterectomy group wanted a definite solution to their problems, whereas patients in the levonorgestrel-releasing IUD group and in the ablation group put greater emphasis on a minimally invasive intervention with or without a short hospital stay. In women undergoing ablation, 70% of the patients preferred this treatment and the levonorgestrel-releasing IUD to hysterectomy in cases in which the success rate of noninvasive treatment was presumed to be 50%. In women having a levonorgestrel-releasing IUD inserted, 95% of the patients preferred this approach over hysterectomy in cases in which the success rate of this device was presumed to be 50%, whereas 35% of patients preferred ablation over hysterectomy in cases in which the success rate of ablation was presumed to be 50%. In women undergoing hysterectomy, 30% would have opted for ablation and 45% would have opted for a levonorgestrel-releasing IUD in cases in which success rates were 50%. Of patients who opted for hysterectomy, however, 60% stated that they would have preferred a noninvasive treatment if the success rate of this type of treatment were >80%.Conclusion(s): A majority of the patients who had dysfunctional uterine bleeding and who were scheduled for an endometrial ablation or a levonorgestrel-releasing IUD were inclined to take a risk of 50% likelihood of treatment failure to avoid a hysterectomy. As a consequence, research of treatment for dysfunctional uterine bleeding should focus on this 50% success level. [Copyright &y& Elsevier]

• Idiopathic heavy menstrual bleeding negatively affects women's quality of life. • The stepped care approach shows practice variation between Dutch hospitals. • Women underwent 0.63 treatments (range, 0.36–1.00) before endometrial ablation. • Women underwent 0.96 treatments (range, 0.56–1.45) before hysterectomy. • Scope exists to reduce hysterectomy rates by implementing less invasive therapies. Heavy menstrual bleeding (HMB) affects a quarter of all women, with half having no structural cause. Dutch guidelines recommend a stepped care approach to the management of such idiopathic HMB, starting with medication or a levonorgestrel-releasing intrauterine device (LNG-IUD), before progressing to endometrial ablation, and ultimately, hysterectomy. However, practice variation between hospitals could lead to suboptimal health outcomes and increased healthcare costs for some women. To evaluate adherence to stepped care for women with idiopathic HMB and to identify practice variation among Dutch hospitals. This population-based cross-sectional study used Dutch insurance claims data from primary and secondary care for all women with idiopathic HMB referred to a gynecologist between January 2019 and December 2020. We calculated the average number of treatments in the 3 years before each treatment step at each hospital, making adjustments for age, socioeconomic status, and ethnicity. Variation in medical practice was measured by the coefficient of variation (CV). We studied 20,715 women treated with LNG-IUDs (56%), endometrial ablation (36%), laparoscopic hysterectomy (13%), or vaginal hysterectomy (4%) in 93 hospitals. Before endometrial ablation, on average 47% used medication (hospital range 27%–71%; CV 0.17) and 16% used an LNG-IUD (hospital range 8%–29%, CV 0.32). Before hysterectomy, 52% (hospital range 28%–65%, CV 0.16) used medication, 21% (hospital range 6%–38%, CV 0.35) used an LNG-IUD, and 23% underwent endometrial ablation (hospital range 0%–59%, CV 0.55). On average, women underwent 0.63 (hospital range 0.36–1.00, adjusted rate 0.40–0.98, CV 0.17) and 0.96 (hospital range 0.56–1.45, adjusted rate 0.56–1.44, CV 0.18) treatments before endometrial ablation and hysterectomy, respectively. Considerable practice variation exists among Dutch hospitals in the stepped care approach to idiopathic HMB. Improving adherence to this approach could improve quality of care and reduce costs. [ABSTRACT FROM AUTHOR]

Background: It is estimated that between 12 to 25% of women who undergo an endometrial ablation for heavy menstrual bleeding (HMB) are dissatisfied after two years because of recurrent menstrual bleeding and/or cyclical pelvic pain, with around 15% of these women ultimately having a hysterectomy. The insertion of a levonorgestrel-releasing intrauterine system (LNG-IUS) immediately after endometrial ablation may inactivate residual untreated endometrium and/or inhibit the regeneration of endometrial tissue. Furthermore, the LNG-IUS may prevent agglutination of the uterine walls preventing intrauterine adhesion formation associated with endometrial ablation. In these ways, insertion of an LNG-IUS immediately after endometrial ablation might prevent subsequent hysterectomies because of persisting uterine bleeding and cyclical pelvic pain or pain that arises de novo. Hence, we evaluate if the combination of endometrial ablation and an LNG-IUS is superior to endometrial ablation alone in terms of reducing subsequent rates of hysterectomy at two years following the initial ablative procedure.Methods/design: We perform a multicentre randomised controlled trial in 35 hospitals in the Netherlands. Women with heavy menstrual bleeding, who opt for treatment with endometrial ablation and without contraindication for an LNG-IUS are eligible. After informed consent, participants are randomly allocated to either endometrial ablation plus LNG-IUS or endometrial ablation alone. The primary outcome is the hysterectomy rate at 24 months following endometrial ablation. Secondary outcomes include women's satisfaction, reinterventions, complications, side effects, menstrual bleeding patterns, quality of life, societal costs.Discussion: The results of this study will help clinicians inform women with HMB who opt for treatment with endometrial ablation about whether concomitant use of the LNG-IUS is beneficial for reducing the need for hysterectomy due to ongoing bleeding and/or pain symptoms. Trial registration Dutch Trial registration: NL7817. Registered 20 June 2019, https://www.trialregister.nl/trial/7817 . [ABSTRACT FROM AUTHOR]

Introduction: Despite endometrial ablation/resection being a very successful treatment for women with heavy menstrual bleeding, re‐intervention with additional surgery is needed in 12%–25% of cases. Introducing a levonorgestrel‐intrauterine system (LNG‐IUS) immediately after ablation could preserve the integrity of the uterine cavity and suppress the regenerated or non‐ablated endometrial tissue. Therefore, this combined treatment can perhaps lower the re‐intervention rate. The aim of this systematic review was to assess the impact of the combined treatment. Material and methods: The MEDLINE, EMBASE, and Cochrane library were systematically searched. No language restrictions were applied. All types of studies were included reporting on the results of endometrial ablation or resection combined with immediate insertion of LNG‐IUS for treatment of heavy menstrual bleeding. The primary outcome was the number of hysterectomies after the ablation procedure. Secondary outcomes included re‐intervention rates, removals of LNG‐IUS, bleeding pattern, patient satisfaction, adverse effects, and complications. Our protocol was registered in PROSPERO, an international prospective register of systematic reviews under registration number CRD42020151384. Results: Six studies with a retrospective design and one case series with a follow‐up duration varying from 6 to 55 months were included. In total, 427 women were treated with the combined treatment. The studies described a lower hysterectomy and re‐intervention rate after combined treatment compared with treatment with endometrial ablation/resection alone. Hysterectomy rate varied from 0% to 11% after combined treatment compared with 9.4% to 24% after endometrial ablation/resection alone. Bleeding patterns and patient satisfaction appeared to be in favor of the combined treatment group. No intra‐ or post‐operative complications or complications in the removal of LNG‐IUS were described. The most reported adverse effects after combined treatment were weight gain, mood changes, and headaches. An additional 11 studies with only an abstract available substantiated these findings. All the included studies had poor methodological quality. Conclusions: Based on the available literature, inserting an LNG‐IUS immediately after endometrial ablation/resection seems to lower the hysterectomy and re‐intervention rates compared with ablation/resection alone. However, as only limited observational studies of low methodological quality are available, high‐quality research is necessary to confirm the findings of this systematic review. [ABSTRACT FROM AUTHOR]

The objective of this study was to compare the reintervention rate of women who opted for treatment with the levonorgestrel-releasing intrauterine system (LNG-IUS) to women who opted for endometrial ablation. Furthermore, the difference in reintervention rate between women in this observational cohort and women who were randomised was compared, with the hypothesis that women who actively decide on treatment have lower reintervention rates compared to women in a RCT. An observational cohort study alongside a multicentre randomised controlled trial (RCT) was conducted between April 2012 and January 2016, with a follow-up time of 24 months, in 26 hospitals and nearby general practices in the Netherlands. Women suffering from heavy menstrual bleeding, aged 34 years and older, without intracavitary pathology and without a future fertility desire, were eligible for this trial. Women who declined randomisation were asked to participate in the observational cohort. The outcome measure was reintervention rate at 24 months of follow-up. 276 women were followed in the observational cohort of which 87 women preferred an initial treatment with LNG-IUS and 189 women preferred an initial treatment with endometrial ablation. At 24 months of follow-up women in the LNG-IUS-group were more likely to receive a reintervention compared to the women in the ablation group, 28/81 (35 %) versus 25/178 (14 %) (aRR 2.42, CI 1.47–3.98, p-value 0.001). No differences in reintervention rates were found between women in the observational cohort and women in the RCT. Women who receive an LNG-IUS are more likely to undergo an additional intervention compared to women who receive endometrial ablation. Reintervention rates of women in the cohort and RCT population were comparable. The results of this study endorse the findings of the RCT and will contribute to shared decision making in women with heavy menstrual bleeding. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to compare the reintervention rate of women who opted for treatment with the levonorgestrel-releasing intrauterine system (LNG-IUS) to women who opted for endometrial ablation. Furthermore, the difference in reintervention rate between women in this observational cohort and women who were randomised was compared, with the hypothesis that women who actively decide on treatment have lower reintervention rates compared to women in a RCT.Study Design: An observational cohort study alongside a multicentre randomised controlled trial (RCT) was conducted between April 2012 and January 2016, with a follow-up time of 24 months, in 26 hospitals and nearby general practices in the Netherlands. Women suffering from heavy menstrual bleeding, aged 34 years and older, without intracavitary pathology and without a future fertility desire, were eligible for this trial. Women who declined randomisation were asked to participate in the observational cohort. The outcome measure was reintervention rate at 24 months of follow-up.Results: 276 women were followed in the observational cohort of which 87 women preferred an initial treatment with LNG-IUS and 189 women preferred an initial treatment with endometrial ablation. At 24 months of follow-up women in the LNG-IUS-group were more likely to receive a reintervention compared to the women in the ablation group, 28/81 (35 %) versus 25/178 (14 %) (aRR 2.42, CI 1.47-3.98, p-value 0.001). No differences in reintervention rates were found between women in the observational cohort and women in the RCT.Conclusions: Women who receive an LNG-IUS are more likely to undergo an additional intervention compared to women who receive endometrial ablation. Reintervention rates of women in the cohort and RCT population were comparable. The results of this study endorse the findings of the RCT and will contribute to shared decision making in women with heavy menstrual bleeding. [ABSTRACT FROM AUTHOR]

Objectives: Women's preferences for treatment of heavy menstrual bleeding (HMB) are important in clinical decision-making. Our aim was to investigate whether women with HMB have a preference for treatment characteristics of the levonorgestrel intrauterine system (LNG-IUS) or endometrial ablation and to assess the relative importance of these characteristics.Study Design: A discrete choice experiment was performed in general practices and gynaecology outpatient clinics in the Netherlands. Women with HMB were asked to choose between hypothetical profiles containing characteristics of LNG-IUS or endometrial ablation. Characteristics included procedure performed by gynaecologist or general practitioner; reversibility of the procedure; probability of dysmenorrhea; probability of irregular bleeding; additional use of contraception; need to repeat the procedure after five years; and treatment containing hormones. Data were analysed using panel mixed logit models. The main outcome measures were the relative importance of the characteristics and willingness to make trade-offs.Results: 165 women completed the questionnaire; 36 (22%) patients were recruited from general practices and 129 (78%) patients were recruited from gynaecology outpatient clinics. The characteristic found most important was whether a treatment contains hormones. Women preferred a treatment without hormones, a treatment with the least side effects, and no need for a repeat procedure or additional contraception. Women completing the questionnaire at the gynaecology outpatient clinic differed from women in primary care in their preference for a definitive treatment to be performed by a gynaecologist.Conclusions: Whether or not a treatment contains hormones was the most important characteristic influencing patient treatment choice for HMB. Participants preferred characteristics that were mostly related to endometrial ablation, but were willing to trade-off between characteristics. [ABSTRACT FROM AUTHOR]

Objective: To compare the effectiveness of bipolar radiofrequency (Novasure®) ablation and balloon endometrial ablation (Thermablate®).Study Design: We performed a multi-center double blind, randomized controlled trial in three hospitals in The Netherlands. Women with heavy menstrual bleeding were randomly allocated to bipolar or balloon endometrial ablation, performed in the office, using a paracervical block. The primary outcome was amenorrhea. Secondary outcome measures were pain, satisfaction, quality of life and reintervention.Results: 104 women were randomized into the bipolar (52) and balloon (52) groups. After 12 months amenorrhea rates were 56% (29/52) in the bipolar group and 23% (12/52) in the balloon group (relative risk (RR) 0.6, 95% confidence interval (CI) 0.4-0.8). The mean visual analog pain score of the total procedure was 7.1 in the bipolar group and 7.4 in the balloon group (P<.577). 87% (45/52) of the patients in the bipolar group were satisfied with the result of the treatment versus 69% (36/52) in the balloon group (RR 0.44, 95% CI 0.2-0.97). The reintervention rates were 5/52 (10%) in the bipolar group and 6/52 (12%) in the balloon group (RR 1.02, 95% CI 0.9-1.2). Quality of life (Shaw score) improved over time (P<.001) and was significantly higher in the bipolar group at 12 months follow-up (P=.025).Conclusion: In the treatment of heavy menstrual bleeding, bipolar radiofrequency endometrial ablation is superior to balloon endometrial ablation as an office procedure in amenorrhea rate, patient satisfaction and quality of life. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To assess whether, among other prognostic factors, a history of Cesarean section is associated with endometrial ablation failure in the treatment of menorrhagia. Study design We compared women who had failed ablation to women who had successful ablation for menorrhagia in a case–control study. Failed ablation was defined as the need for hysterectomy due to persistent heavy menstrual bleeding after ablation. Successful ablation was defined as an ablation for menorrhagia not needing hysterectomy and the woman being satisfied with the result. Both cases and controls were identified from the surgery registration in the Máxima Medical Center between January 1999 and January 2009. Cases were women that had an endometrial ablation and a hysterectomy, whereas controls only had an endometrial ablation. From the medical files we collected for each patient clinical history, including the presence of a previous Cesarean section, baseline characteristics at the moment of initial ablation, data of the ablation technique and follow-up status. We used univariable and multivariable logistic regression to estimate the risk of failure of endometrial ablation. Results: We compared 76 cases to 76 controls. Among the cases, 12 women had had a previous Cesarean section versus 15 in the control group (15.8% versus 19.7%; odds ratio (OR) 0.76; 95% CI 0.3–1.8). Factors predictive for failure of ablation were dysmenorrhea (OR 3.0; 95% CI 1.5–6.1), having a submucous myoma (OR 3.2; 95% CI 1.5–6.8) and uterine depth (per cm OR 1.3; 95% CI 1.0–1.6). Presence of intermenstrual bleeding, sterilization and age were not associated with failure of ablation. Conclusion: A previous Cesarean delivery is not associated with an increased risk of failure of endometrial ablation, but dysmenorrhea, a submucous myoma and longer uterine depth are. This should be incorporated in the counseling of women considering endometrial ablation. [Copyright &y& Elsevier]