This Health technology assessment aimed to determine the clinical effectiveness and cost-effectiveness of hysterectomy, first- and second-generation endometrial ablation (EA), and Mirena® for the treatment of heavy menstrual bleeding.

Data from women undergoing treatment for heavy menstrual bleeding were obtained from national and international trials. Scottish national data were obtained from the Scottish Information Services Division. The main outcome measures were satisfaction, recurrence of symptoms, further surgery and costs. The following findings were reported:

• 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% 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 duration of 6.2 and 11.6 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, women who had undergone ablation were less likely to need pelvic floor repair and tension-free vaginal tape surgery for stress urinary incontinence. Abdominal hysterectomy led to a lower chance of pelvic floor repair surgery 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.

This assessment concluded “despite longer hospital stay and time to resumption of normal activities, more women were satisfied after hysterectomy than after endometrial ablation. There is some suggestion that Mirena is potentially cheaper and more effective than first-generation ablation techniques, with rates of satisfaction similar to second-generation techniques; there is limited evidence to suggest that hysterectomy is preferable to Mirena. Although the most cost-effective strategy, hysterectomy may not be considered an initial option owing to its invasive nature and higher risk of complications.”