Second-generation Endometrial Ablation Research Articles

Trends in first-generation endometrial ablation procedures performed in a district general hospital, 1995–2005

Heavy menstrual bleeding is a common presenting complaint and can significantly affect the quality of life of affected women. The 2007 National Institute for Clinical Excellence guideline on heavy menstrual bleeding states that in women with heavy menstrual bleeding alone, endometrial ablation should be considered preferable to hysterectomy. The choice of the type of endometrial ablation procedure would depend on several factors including the availability of first-, second- or even third-generation endometrial ablation equipment, clinician experience and preference as well as patient choice and if procedure is intended to be performed as an office procedure without the use of general anaesthetic where second- or third-generation endometrial ablation equipment would be used. The number of first-generation endometrial ablation procedures being performed is expected to decrease over time. This is as a result of clinicians’ preference, due to reported higher operative complication rates in some studies, even though a meta-analysis of individual patient data has found it to be as effective as the second-generation techniques for heavy menstrual bleeding. We performed a retrospective clinical audit to investigate the trend from January 1995 to December 2005 in the use of first-generation endometrial ablation techniques performed at a district general hospital in the UK. We found that the general trend is of a rapidly decreasing number of first-generation endometrial ablation procedures being performed. We also found that the operative complication rates are low and similar to rates in the published literature. The long-term hysterectomy rate after first-generation endometrial ablation procedure in our audit population is also low and similar to the rates in the published literature. We conclude from our audit data that first-generation endometrial ablation techniques such as trans-cervical resection of the endometrium for heavy menstrual bleeding are effective and in experienced hands have fairly low operative complication rates and long-term hysterectomy rates. These are similar to rates in the published literature for second-generation endometrial ablation techniques. We recommend that until further larger scale randomised controlled trials comparing first generation and the newer second-generation endometrial ablation techniques are performed which would provide clinicians with better evidence, first-generation endometrial ablation equipment should not yet be condemned to gather dust in hospital storage facilities and become ‘museum pieces’. Rather, a concerted effort must be made to increase training opportunities in the use of first-generation endometrial ablation techniques especially in institutions that have already made the financial investment and are in possession of perfectly functioning equipment. This would ensure that the valuable clinical skill in the use of available first-generation endometrial ablation technique is not lost over time.

Endometrial Ablation: Is Tubal Ligation a Risk Factor for Hysterectomy

Study ObjectiveTo determine whether tubal ligation is a risk factor for future hysterectomy after second-generation endometrial ablation. DesignRetrospective chart review (Canadian Task Force classification II-3). SettingResident-run clinic and private office in a community setting. PatientsFive hundred eighty-seven patients who underwent endometrial ablation. InterventionsPatients underwent endometrial ablation using either radiofrequency or thermal balloon. Data collected included age, body mass index, uterine length, and endometrial stripe, as well as smoking status and presence or absence of hypertension and hypothyroidism. Indication for hysterectomy and pathologic findings at hysterectomy were also examined. Measurements and Main ResultsThere was no association between tubal ligation and second-generation endometrial ablation resulting in hysterectomy (p = .09). Statistically significant variables included endometrial stripe (p <.001) and smoking (p <.001). There was no statistical significance between the groups insofar as type of ablation, age, body mass index, uterine length, hypertension, or hypothyroidism. Time from endometrial ablation to hysterectomy between groups was not significant. Indication for hysterectomy and pathologic findings after hysterectomy were also not significant. ConclusionsTubal ligation is not a statistically significant risk factor for hysterectomy after endometrial ablation. Tubal ligation does not affect the length of time from endometrial ablation to hysterectomy.

PIH22 - Comparative Direct And Indirect Costs Of Menorrhagia Treatment With Global Endometrial Ablation Or Hysterectomy

• Menorrhagia, or heavy menstrual bleeding, is a common gynecological disorder affecting about one-third of women at some time in their lives.1 • Menorrhagia is the presenting symptom for the majority of women who undergo a hysterectomy.2,3 • While serious complications from menorrhagia are rare, patients’ quality of life is significantly impacted by this condition.4 • Treatment for menorrhagia can be pharmacological and/or surgical. Surgical treatments include uterine artery embolization, myomectomy, hysterectomy, first-generation endometrial ablation methods (rollerball or laser ablation and transcervical resection of endometrium), and second-generation endometrial ablation methods (laser intrauterine thermotherapy, cryoablation, and microwave, thermal balloon, or radiofrequency ablation). • Endometrial ablation methods are very effective and have a low complication rate and high satisfaction rate, but there are varying rates of reintervention associated with ablation, depending on the chosen technology and circumstances under which it is used.5 • Treatment with hysterectomy is effective and permanent; however, there are high rates of morbidity and costs.5,6 BACKGROUND

Hysterectomy, endometrial ablation and Mirena® for heavy menstrual bleeding: a systematic review of clinical effectiveness and cost-effectiveness analysis

The aim of this project was to determine the clinical effectiveness and cost-effectiveness of hysterectomy, first- and second-generation endometrial ablation (EA), and Mirena® (Bayer Healthcare Pharmaceuticals, Pittsburgh, PA, USA) for the treatment of heavy menstrual bleeding. Individual patient data (IPD) meta-analysis of existing randomised controlled trials to determine the short- to medium-term effects of hysterectomy, EA and Mirena. A population-based retrospective cohort study based on record linkage to investigate the long-term effects of ablative techniques and hysterectomy in terms of failure rates and complications. Cost-effectiveness analysis of hysterectomy versus first- and second-generation ablative techniques and Mirena. Data from women treated for heavy menstrual bleeding were obtained from national and international trials. Scottish national data were obtained from the Scottish Information Services Division. Women who were undergoing treatment for heavy menstrual bleeding were included. Hysterectomy, first- and second-generation EA, and Mirena. Satisfaction, recurrence of symptoms, further surgery and costs. Data from randomised trials indicated that at 12 months more women were dissatisfied with first-generation EA than hysterectomy [odds ratio (OR): 2.46, 95% confidence interval (CI) 1.54 to 3.93; p = 0.0002), but hospital stay [WMD (weighted mean difference) 3.0 days, 95% CI 2.9 to 3.1 days; p < 0.00001] and time to resumption of normal activities (WMD 5.2 days, 95% CI 4.7 to 5.7 days; p < 0.00001) were longer for hysterectomy. Unsatisfactory outcomes associated with first- and second-generation techniques were comparable [12.2% (123/1006) vs 10.6% (110/1034); OR 1.20, 95% CI 0.88 to 1.62; p = 0.2). Rates of dissatisfaction with Mirena and second-generation EA were similar [18.1% (17/94) vs 22.5% (23/102); OR 0.76, 95% CI 0.38 to 1.53; p = 0.4]. Indirect estimates suggested that hysterectomy was also preferable to second-generation EA (OR 2.32, 95% CI 1.27 to 4.24; p = 0.006) in terms of patient dissatisfaction. The evidence to suggest that hysterectomy is preferable to Mirena was weaker (OR 2.22, 95% CI 0.94 to 5.29; p = 0.07). In women treated by EA or hysterectomy and followed up for a median [interquartile range (IQR)] duration of 6.2 (2.7-10.8) and 11.6 (7.9-14.8) years, respectively, 962/11,299 (8.5%) women originally treated by EA underwent further gynaecological surgery. While the risk of adnexal surgery was similar in both groups [adjusted hazards ratio 0.80 (95% CI 0.56 to 1.15)], women who had undergone ablation were less likely to need pelvic floor repair [adjusted hazards ratio 0.62 (95% CI 0.50 to 0.77)] and tension-free vaginal tape surgery for stress urinary incontinence [adjusted hazards ratio 0.55 (95% CI 0.41 to 0.74)]. Abdominal hysterectomy led to a lower chance of pelvic floor repair surgery [hazards ratio 0.54 (95% CI 0.45 to 0.64)] than vaginal hysterectomy. The incidence of endometrial cancer following EA was 0.02%. Hysterectomy was the most cost-effective treatment. It dominated first-generation EA and, although more expensive, produced more quality-adjusted life-years (QALYs) than second-generation EA and Mirena. The incremental cost-effectiveness ratios for hysterectomy compared with Mirena and hysterectomy compared with second-generation ablation were £1440 per additional QALY and £970 per additional QALY, respectively. Despite longer hospital stay and time to resumption of normal activities, more women were satisfied after hysterectomy than after EA. The few data available suggest that Mirena is potentially cheaper and more effective than first-generation ablation techniques, with rates of satisfaction that are similar to second-generation techniques. Owing to a paucity of trials, there is limited evidence to suggest that hysterectomy is preferable to Mirena. The risk of pelvic floor surgery is higher in women treated by hysterectomy than by ablation. Although the most cost-effective strategy, hysterectomy may not be considered an initial option owing to its invasive nature and higher risk of complications. Future research should focus on evaluation of the clinical effectivesness and cost-effectiveness of the best second-generation EA technique under local anaesthetic versus Mirena and types of hysterectomy such as laparoscopic supracervical hysterectomy versus conventional hysterectomy and second-generation EA. The National Institute for Health Research Health Technology Assessment programme.

Practical Tips for Office Hysteroscopy and Second-Generation “Global” Endometrial Ablation

Hysteroscopy and endometrial ablation using the second-generation devices are safe, generally well tolerated, and effective when performed in the medical office as opposed to the ambulatory surgery center or hospital operating room. Not only does this benefit the patient and physician in terms of convenience and cost savings, and the overall economic benefit to the health care system is great. The availability of modern hysteroscopic and video equipment, the advent of second-generation “global”endometrial ablation devices, and use of minimal sedation combined with effective local anesthesia have made office procedures possible. Several states have enacted specific regulations and requirements for office based surgery. It is incumbent on the physician to be aware of which local regulations are applicable and the level of procedure he or she is willing to perform before embarking on an office-based surgery program. The AAGL ListServ discussion forum provides members with an invaluable source of clinical opinion about patient care issues in minimally invasive gynecology. These opinions come from experts around the world representing both academic centers and clinical practice who respond to questions or issues posed by colleagues. This review discusses each of the second-generation endometrial ablation devices in detail and some of the more pertinent issues related to office hysteroscopy and global endometrial ablation that were posted on the ListServ. Rollerball and transcervical resection of the endometrium are not discussed because the overwhelming majority of these procedures are performed in the operating room and there is little potential for their becoming office procedures. Practical clinical tips based on the evidence in the literature are discussed.

Levonorgestrel-Releasing Intrauterine System and Endometrial Ablation in Heavy Menstrual Bleeding

To compare the effects of the levonorgestrel intrauterine system and endometrial ablation in reducing heavy menstrual bleeding. Medline and EMBASE were searched online using Ovid up to January 2009, as well as the reference lists of published articles, to identify randomized controlled trials comparing the levonorgestrel intrauterine system with endometrial ablation in the treatment of heavy menstrual bleeding. This systematic review and meta-analysis was restricted to randomized controlled trials in which menstrual blood loss was reported using pictorial blood loss assessment chart scores. Six randomized controlled trials that included 390 women (levonorgestrel intrauterine system, n=196; endometrial ablation, n=194) were retrieved. Three studies pertained to first-generation endometrial ablation (manual hysteroscopy) and three to second-generation endometrial ablation (thermal balloon). Study characteristics and quality were recorded for each study. Data on the effect of treatment on pictorial blood loss assessment chart scores were abstracted, integrated with meta-analysis techniques, and presented as weighted mean differences. Both treatment modalities were associated with similar reductions in menstrual blood loss after 6 months (weighted mean difference, -31.96 pictorial blood loss assessment chart score [95% confidence interval (CI), -65.96 to 2.04]), 12 months (weighted mean difference, 7.45 pictorial blood loss assessment chart score [95% CI, -12.37 to 27.26]), and 24 months (weighted mean difference, -26.70 pictorial blood loss assessment chart score [95% CI, -78.54 to 25.15]). In addition, both treatments were generally associated with similar improvements in quality of life in five studies that reported this as an outcome. No major complications occurred with either treatment modality in these small trials. Based on the meta-analysis of six randomized clinical trials, the efficacy of the levonorgestrel intrauterine system in the management of heavy menstrual bleeding appears to have similar therapeutic effects to that of endometrial ablation up to 2 years after treatment.

Transcervical intrauterine bupivacaine for the management of postoperative pain following endometrial balloon ablation—a pre-trial toxicity study

The success of second-generation endometrial ablation performed as day case or outpatient procedure is often hampered by severe postoperative pain. We administered dilute bupivacaine solution into the uterine cavity soon after balloon ablation in ten consecutive women, looking at the safety profile of bupivacaine. Three hours postoperative serum bupivacaine levels were well below the toxic level in all women with no side effects reported.

Balloon Endometrial Ablation Under Hysteroscopic Control of Septate Uterus Complicated by Postcesarean Scar Defect

Use of second-generation endometrial ablation devices has largely supplanted hysteroscopic resection and rollerball ablation for treatment of menorrhagia. Pathology of the uterus may be diagnosed immediately before endometrial ablation procedure using these newer instruments, making the chosen device inappropriate and requiring a change in planned procedure. Preprocedural assessment with 1 or a combination of transvaginal ultrasound (TVS), saline-infusion sonography, and hysteroscopy is necessary to identify suitability for preferred technique. TVS is frequently used as the only investigation to assess uterine cavity, and undiagnosed or missed pathology on TVS may render chosen endometrial ablation procedure inappropriate. Previously undiagnosed septate uterus and postcesarean scar defect were diagnosed at hysteroscopy immediately before endometrial ablation, but missed by routine TVS. Balloon endometrial ablation in the septate uterus was used.

A survey of preferences and practices of endometrial ablation/resection for menorrhagia in the United Kingdom

To survey the preferences and variations in the current use of first- and second-generation endometrial ablative techniques for menorrhagia among the consultant gynecologists in the United Kingdom, given the call for further studies to systematically compare the clinical effectiveness of the various endometrial ablation techniques. Postal questionnaire survey. One thousand, four hundred sixty consultant gynecologists in the United Kingdom. Preferred endometrial ablation/resection method and variations in the current practices. Six hundred ten (41%) consultants responded. Of these, 449 (73%) performed endometrial ablation/resection. Thermal balloon ablation (32.1%) was the preferred method, followed by microwave endometrial ablation (29.8%), transcervical resection of the endometrial alone or combined with roller ball diathermy (18.5%), Novasure (9.8%), hydrotherm ablation (6.9%), roller ball (2%), and laser (0.9%). Patient response to treatment was assessed using clinical history (64.3%), menstrual calendar (7.6%), clinical history and menstrual calendar (21.3%), questionnaires (5.8%), and pictorial blood loss assessment charts (0.4%). A total of 52.2% used gonadotrophin releasing hormone analogues preoperatively. Variations in techniques for transcervical resection of the endometrial included methods used to treat the uterine fundus and cornuae, fluid management, and operating pressures. Second-generation endometrial ablation devices were preferred to first-generation devices for the management of menorrhagia. Thermal balloon ablation was the most preferred method. However, variations in surgical practices will make assessment of clinical efficacy a challenge.

Clinical and health service implications of second generation endometrial ablation devices

This review evaluates the current evidence on the efficacy, safety and cost-effectiveness of the ever-increasing number of second-generation endometrial ablation devices. The literature covered by this review includes (1) evidence on long-term benefit, avoidance of hysterectomy and improvement in quality of life, (2) applicability of these techniques in the outpatient environment under local or no anaesthesia, (3) frequency and nature of early and delayed complications associated with these devices, (4) impact on clinical practice and the health service, and (5) implications for research. Where appropriate, second-generation devices are rapidly becoming the first-line surgical choice for the management of heavy menstrual bleeding. This has both cost-savings and negative implications for the health service. There is also emerging evidence that improvement in quality of life is more relevant to women than amenorrhoea rates. What has come to light from this review is the lack of accurate data on adverse events rate, and the urgent need for a better appreciation of the frequency and nature of complications.

Thermal balloon endometrial ablation (Cavaterm) in the management of menorrhagia

The most frequently used second-generation endometrial ablation techniques in UK clinical practice are fluid filled thermal balloon endometrial ablation and microwave endometrial ablation (NICE 200...

An update on second-generation devices for endometrial ablation

Menorrhagia is a very common problem. Hysterectomy has been the traditional surgical treatment of choice guaranteeing amenorrhoea. It is 100% effective but is associated with surgical complications, and is more costly in terms of economic impact and recovery time. Minimally invasive procedures to ablate the endometrium reduce complications and recovery time. The newer second-generation endometrial ablation devices negate the need for surgery under direct hysteroscopic vision, thus ensuring that the treatments are not operator dependent. However, they heavily rely on the device themselves to ensure safety and efficacy. There are a variety of these devices currently available on the market. The authors will review these devices and provide the evidence for their suitability in various settings.

The impact of endometrial ablation technique at a large university women's hospital

To determine the effect of ThermaChoice uterine balloon system on the practice patterns of endometrial ablations performed at a large university-based teaching hospital. A retrospective chart review was conducted of 226 patients who underwent endometrial ablation. Data were analyzed to determine any change in the type and rate of ablations performed since the introduction of second-generation technologies. Multivariate logistic regression models were used to estimate adjusted risk factors for subsequent admission. A total of 72.1% of all cases were performed with the ThermaChoice uterine balloon. The postoperative admission rate was significantly higher after a balloon procedure (13.7% versus 3.1%, P=.02), with a 10.6% overall incidence of admission. Adjusting for confounding variables, more women were admitted after a balloon procedure, compared with women undergoing hysteroscopic ablation (odds ratio 5.0; 95% CI: 1.1, 22). Second-generation endometrial ablation technologies represent frequently utilized and proficient treatment modalities for dysfunctional uterine bleeding. Notwithstanding their facilitative design, clinicians should not lose sight of potential limitations of these new procedures.

Beware: pregnancy and second-generation endometrial ablation

With the promotion of second-generation endometrial ablative techniques—namely thermal balloon endometrial ablation and microwave endometrial ablation—as alternatives to hysterectomy for dysfunctional uterine bleeding, with phrases like “three-minute hysterectomy,” some women become complacent about contraception after ablation. Some even assume that “hysterectomy,” as widely used in the popular press, means “no more children.” Pregnancy after endometrial ablation does not represent a failure of the technique. The failure is due to poor counselling or to women not taking the advice to use appropriate contraception after the procedure.

A cost-utility analysis of microwave and thermal balloon endometrial ablation techniques for the treatment of heavy menstrual bleeding.

To assess the cost effectiveness of the second-generation surgical treatments for heavy menstrual bleeding (microwave and thermal balloon endometrial ablation) compared with existing endometrial ablation techniques (transcervical resection and rollerball, alone or in combination) and hysterectomy. A state transition (Markov) cost-utility economic model. Women with heavy menstrual bleeding. A Markov model was developed using spreadsheet software. Transition probabilities, costs and quality of life data were obtained from a systematic review of effectiveness undertaken by the authors, from published sources, and expert opinion. Cost data were obtained from the literature and from a NHS trust hospital. Indirect comparison of thermal balloon endometrial ablation versus microwave endometrial ablation or either second-generation endometrial ablation method versus hysterectomy, and comparison of second-generation versus first-generation techniques were carried out from the perspective of health service payers. The effects of uncertainty were explored through extensive one-way sensitivity analyses and Monte Carlo simulation. Incremental cost effectiveness ratios based on cost per quality adjusted life year (QALY) gained, and cost effectiveness acceptability curves. Compared with first-generation techniques, both microwave and thermal balloon endometrial ablation cost less and accrued more QALYs. Hysterectomy was more expensive, but accrued more QALYs than all endometrial ablation methods. Baseline results showed that differences between microwave endometrial ablation and thermal balloon endometrial ablation were slight. Sensitivity analyses showed that small changes in values may have a marked effect on cost effectiveness. Probabilistic simulation highlighted the uncertainty in comparisons between different endometrial ablation options, particularly between second-generation techniques. Despite limitations in available data, the analysis suggests that second-generation techniques are likely to be more cost effective than first-generation techniques in most cases. Hysterectomy, where a woman finds this option acceptable, continues to be a very cost effective procedure compared with all endometrial ablation methods.

The effectiveness and cost-effectiveness of microwave and thermal balloon endometrial ablation for heavy menstrual bleeding: a systematic review and economic modelling.

To estimate the clinical effectiveness and cost-effectiveness of microwave endometrial ablation (MEA) and thermal balloon endometrial ablation (TBEA) for heavy menstrual bleeding (HMB), compared with the existing (first-generation) endometrial ablation (EA) techniques of transcervical resection (TCRE) and rollerball (RB) ablation, and hysterectomy. Electronic databases, bibliographies of articles, and also experts in the field and relevant industry bodies were asked to provide information. A detailed search strategy was carried out to identify systematic reviews and controlled trials of MEA and TBEA versus first-generation techniques for EA. In addition to electronic database searching, reference lists were hand-searched and information sought from manufacturers of EA devices and by experts in the field. A deterministic Markov model was developed to assess cost-effectiveness. Data for the model were taken from a range of sources. The systematic review of first-generation EA techniques versus hysterectomy found that EA offered an alternative to hysterectomy for HMB, with fewer complications and a shorter recovery period. Satisfaction and effectiveness were high for both MEA and TBEA. Costs were lower with EA although the difference narrows over time. Second-generation EA techniques are an alternative treatment to first-generation techniques for HMB, and first-generation techniques are known to offer an alternative to hysterectomy. Although no trials of second-generation techniques and hysterectomy have been undertaken, it seems reasonable to assume that second-generation techniques also offer an alternative surgical treatment. Using the model to assess cost-effectiveness, costs were very slightly higher for MEA when compared to TBEA, and differences in quality-adjusted life-years (QALYs) were negligible. For MEA compared with transcervical resection of the endometrium (TCRE) and RB ablation, costs were slightly lower with MEA and MEA accrued very slightly more QALYs. Compared with hysterectomy, MEA costs less and accrues slightly fewer QALYs. For TBEA compared with TCRE and RB ablation, costs were lower with TBEA and TBEA accrued slightly more QALYs. Compared with hysterectomy, TBEA costs moderately less and accrues moderately fewer QALYs. Overall, there were few significant differences between the outcomes of first- and second-generation techniques including bleeding, satisfaction and QoL measures and repeat surgery rates. Second-generation techniques had significantly shorter operating and theatre times and there appear to be fewer serious perioperative adverse effects with second-generation techniques and postoperative effects are similar. Compared with hysterectomy, TCRE and RB are quicker to perform and result in shorter hospitalisation and faster return to work. Hysterectomy results in more adverse effects and is more expensive, although the need for retreatment leads this difference to decrease over time. Satisfaction with hysterectomy is initially higher, but there is no significant difference after 2 years. The economic model suggests that second-generation techniques are more cost-effective than first-generation techniques of EA for HMB. Both TBEA and MEA appear to be less costly than hysterectomy, although the latter results in more QALYs. Further research is suggested to make direct comparisons of the cost-effectiveness of second-generation EA techniques, to carry out longer term follow-up for all methods of EA in RCTs, and to develop more sophisticated modelling studies. Further research is also recommended into HMB to establish health-state utility values, its surgical treatment, convalescence, complications of treatment, symptoms and patient satisfaction.

Quality of Life Should Be Considered the Primary Outcome for Measuring Success of Endometrial Ablation

Study Objective To compare clinical and quality of life outcomes by validated instruments after endometrial ablation by four methods, and determine the primary outcome that most reflects procedure success. Design Descriptive cohort study (Canadian Task Force classification II-2). Setting Minimal-access gynecologic surgery unit in northeast England. Patients One hundred thirty-nine women. Intervention Endometrial ablation by one of four methods: Cavaterm, endometrial laser interstitial thermotherapy (ELITT), endometrial laser ablation (ELA), or NovaSure impedance-controlled system. Measurements and Main Results Clinical outcomes were assessed according to menstrual outcome. Whereas amenorrhea rates were significantly different among the four techniques (χ 2 = 9.42, p = 0.02), combined amenorrhea and hypomenorrhea rates were not significantly different (67%, 69%, 69%, 62%, χ 2 = 0.38, NS) for Cavaterm, ELITT, ELA, and NovaSure, respectively. Quality of life, measured preoperatively by the EQ-5D index and EQ-5D vas, SF-12 physical and mental component scores, and sexual activity questionnaire pleasure, habit, and discomfort scores, were substantially improved 12 months after treatment. No significant differences were seen in quality of life scores between women after endometrial ablation and the general population. Conclusion Quality of life for women with menorrhagia is improved to a normal level by treatment with either first- or second-generation endometrial ablation.

A double-blind randomized trial comparing the Cavaterm ™ and the NovaSure ™ endometrial ablation systems for the treatment of dysfunctional uterine bleeding

Objective To compare two second-generation endometrial ablation systems in women with dysfunctional uterine bleeding (DUB) who want conservative surgical treatment. Design A double-blind, randomized trial. Setting A minimal access gynecological surgery unit in northeast England. Patient(s) Fifty-seven women diagnosed with DUB were recruited, with 55 undergoing surgery and completing 12-month follow-up. Intervention(s) Thirty-seven women underwent a NovaSure ™ endometrial ablation, and 18 had a Cavaterm ™ endometrial ablation. Clinical and quality of life data were collected 6 and 12 months after treatment. Main outcome measure(s) Amenorrhea, menstrual change, quality of life, sexual activity, patient satisfaction, and procedure acceptability. Result(s) Amenorrhea, hypomenorrhea, eumenorrhea, and menorrhagia rates for the Cavaterm ™ and Novasure ™ groups at 12 months were 2/18 (11%) vs. 16/37 (43%); 11/18 (61%) vs. 10/37 (27%); 5/18 (27%) vs. 6/37 (16%); and 0/18 vs. 5/37 (13%), respectively. At 12 months, 83% and 92% of women were either satisfied or very satisfied in the Cavaterm ™ or Novasure ™ groups, respectively. There were no major complications in either group. Conclusion(s) Both the Cavaterm ™ and the Novasure ™ endometrial ablation systems are effective in reducing menstrual loss in women with DUB and achieve high rates of patient satisfaction. The Novasure ™ system achieved a statistically significantly higher rate of amenorrhea in this study.

Uterine endometrial thermal balloon therapy for the treatment of menorrhagia: long-term multicentre follow-up study.

Initial reports from observational and randomized trials of uterine endometrial thermal balloon therapy (UBT) suggested good results as judged by return to eumenorrhoea or less and patient satisfaction. Long-term follow-up data remained limited by the small numbers of patients and duration of follow-up. We present long-term (4-6 years) follow-up data from a cohort of women previously treated with UBT for menorrhagia. Of the 260 questionnaires sent to women eligible for long-term follow-up from 10 centres, 188 (72%) replies were received. The primary outcome measure was avoidance of hysterectomy. In women who responded to the questionnaire, 25 had undergone hysterectomy and 21 had had repeat ablation. At 4-6 years after UBT, the probability of avoiding hysterectomy was 86% of all women, and of avoiding re-ablation was 88% of non-hysterectomized women. Overall, the probability of avoiding any surgery was 75%. Women with an axial or retroverted uterus were at greater risk of hysterectomy or re-ablation. Among the participants, 47% of the non-hysterectomized women were amenorrhoeic, 30% were hypomenorrhoeic, 13.6% were eumenorrhoeic and 8.5% had heavy periods. This is the first long-term follow-up report of a second-generation endometrial ablation procedure and confirms our initial experience. The high rate of hysterectomy avoidance over 5 years or more is very encouraging for this technology.