Levonorgestrel-releasing intrauterine system vs. usual medical treatment for menorrhagia: an economic evaluation alongside a randomised controlled trial.

OBJECTIVE: To undertake an economic evaluation alongside the largest randomised controlled trial comparing Levonorgestrel-releasing intrauterine device ('LNG-IUS') and usual medical treatment for women with menorrhagia in primary care; and compare the cost-effectiveness findings using two alternative measures of quality of life. METHODS: 571 women with menorrhagia from 63 UK centres were randomised between February 2005 and July 2009. Women were randomised to having a LNG-IUS fitted, or usual medical treatment, after discussing with their general practitioner their contraceptive needs or desire to avoid hormonal treatment. The treatment was specified prior to randomisation. For the economic evaluation we developed a state transition (Markov) model with a 24 month follow-up. The model structure was informed by the trial women's pathway and clinical experts. The economic evaluation adopted a UK National Health Service perspective and was based on an outcome of incremental cost per Quality Adjusted Life Year (QALY) estimated using both EQ-5D and SF-6D. RESULTS: Using EQ-5D, LNG-IUS was the most cost-effective treatment for menorrhagia. LNG-IUS costs £100 more than usual medical treatment but generated 0.07 more QALYs. The incremental cost-effectiveness ratio for LNG-IUS compared to usual medical treatment was £1600 per additional QALY. Using SF-6D, usual medical treatment was the most cost-effective treatment. Usual medical treatment was both less costly (£100) and generated 0.002 more QALYs. CONCLUSION: Impact on quality of life is the primary indicator of treatment success in menorrhagia. However, the most cost-effective treatment differs depending on the quality of life measure used to estimate the QALY. Under UK guidelines LNG-IUS would be the recommended treatment for menorrhagia. This study demonstrates that the appropriate valuation of outcomes in menorrhagia is crucial.

Hysteroscopic local anaesthetic intrauterine cornual 'focal local' block before endometrial ablation with direct cervical block in an outpatient setting: a feasibility study.

OBJECTIVE: To evaluate the safety, feasibility and efficacy of a hysteroscopic local anaesthetic intrauterine cornual block (ICOB) on women's perception of pain during outpatient Thermachoice endometrial ablation (TEA). STUDY DESIGN: Pre-menopausal women with heavy menstrual bleeding undergoing TEA were included in the study. The intervention used, ICOB, was a hysteroscopic injection of local anaesthetic into the myometrium just medial to each tubal ostium. The women also had a traditional direct cervical block (DCB). We measured the acceptability of ICOB and the pain score (visual analogue score scale) immediately after the procedure. RESULTS: We treated 30 patients (mean age 41 years, SD 6; BMI 29±7) between January 2012 and December 2012. All patients had a successful ICOB block and found TEA with ICOB acceptable. The mean VAS score was 3.5±2.7, which was two points lower compared to our earlier prospective cohort of patients undergoing TEA with only a DCB (mean 5.8±2.7, n=102). No serious complications occurred during the procedure or postoperatively. Three patients experienced a vasovagal response which resolved spontaneously. CONCLUSION: ICOB with DCB is a safe, feasible and efficacious method of pain control during TEA. There is however a need to evaluate efficacy of ICOB in a randomised placebo controlled trial.

Outpatient thermal balloon ablation of the endometrium.

OBJECTIVE: To determine the feasibility and potential efficacy of thermal balloon ablation of the endometrium in the outpatient setting without the need for general anesthesia or conscious sedation. DESIGN: Prospective observational study. SETTING: Outpatient hysteroscopy clinic in a university-affiliated teaching hospital. PATIENT(S): Fifty-three consecutively recruited women with menorrhagia that was unresponsive to medical treatment. INTERVENTION(S): Thermal balloon endometrial ablation using local anesthetic without conscious sedation. MAIN OUTCOME MEASURE(S): Procedure feasibility, change in menstrual symptoms, and patient satisfaction and quality of life (Menorrhagia Utility Scale and EuroQol) at 6-month follow-up. RESULT(S): Thermal balloon ablation was successfully completed in 50 (94%) of 53 women. The three failed procedures consisted of one case in which the woman could not tolerate the procedure because of severe discomfort, one case of equipment failure, and one case in which the balloon catheter could not be inserted into the uterine cavity. Completed outcome questionnaires were returned by 49 (98%) of 50 treated women. Improvement in menstrual loss was experienced by 39 (80%) of 49 women, and satisfaction with the outcome of treatment on menstrual symptoms was reported by 33 (67%) of 49 women. Significantly higher condition-specific quality-of-life scores were associated with treatment satisfaction. CONCLUSION(S): Thermal balloon ablation of the endometrium is feasible in the outpatient setting. Improvement in menstrual symptoms and satisfaction with the outcome of treatment appear to be comparable to published inpatient data. Further studies are required to determine the cost-effectiveness of outpatient compared with inpatient thermal balloon therapy.