Clinical Evidence
MEA has been submitted to extensive international randomised controlled clinical trials (RCTs):
- MEA versus Rollerball Endometrial Ablation (REA)1
- MEA carried out under Local Anaesthetic (LA) versus MEA carried out under General Anaesthetic (GA)2
- MEA versus trans-cervical resection of the endometrium (TCRE)3
- MEA vs Rollerball Endometrial Ablation (REA)
Prospective, randomised analysis of 324 subjects with a 2:1 ratio of treatment (MEA) versus control (REA) with evaluation at 3, 6, and 12 months. Additional follow-up will be completed at 2 and 3 years post procedure.
The recruitment for the trail was based upon women who were pre-menopausal and aged 30 and above, had a PBLAC score greater than or equal to 185, with a uterine cavity of sounding length between 6 to 14cm and with an endometrial cavity that was not obstructed by fibroids less than or equal to 3cm.
Trial Results
- MEA produced better results than REA, with a reduced bleeding rate of 96% and an amenorrhoea rate of 61%.
- This outstanding rate for amenorrhoea was maintained in patients with fibroids i.e. 61% MEA versus 38.5% REA.
- Overall a patient satisfaction rate of 98.5% was recorded for MEA.
In Addition
63% of MEA patients were treated under local anaesthesia with IV sedation versus 24% for REA.
The average MEA procedure took 3.45 minutes versus 20.26 minutes for REA.
1 Microsulis Microwave Endometrial Ablation (MEA) System Data PMA No. P02003
2 "A randomised trial comparing local versus general anaesthesia for microwave endometrial ablation" Wallage S, Cooper K. G., Graham W. J. and Parkin D. E. : BJOG 2003, Vol 110 (Part 9) Pages 799-807
3 "Microwave endometrial ablation versus endometrial resection: a randomised controlled trial" Bain, C. Cooper K. G. Parkin, D. E.; Obstet Gynecol 99 (6) 2002
Clinical Evidence
MEA carried out under Local Anaesthetic (LA) versus MEA carried out under General Anaesthetic (GA)
MEA versus Trans-cervical Resection of the Endometrium (TCRE)
Both of these Grade A RCTs were carried out by an independent research group at Aberdeen Royal Infirmary (ARI). ARI adopted a "pragmatic" approach to patient inclusion - specifically the uterus could be up to the size of a 10 week pregnancy and fibroids were not excluded.
MEA under LA vs MEA under GA
190 women were equally randomised to MEA under LA versus MEA under GA. The results confirmed that MEA under LA, with sedation if requested, was acceptable to the vast majority of women referred for treatment and was not associated with any complications
- 96% of women who chose LA would have the same treatment
- 89% of women who were randomised to LA would have the same treatment again
- 87% of patients found MEA under LA to be totally or generally acceptable
MEA vs TCRE
263 women were randomised to MEA or TCRE.
The results demonstrated that MEA is equivalent to TCRE in terms of relieving symptoms and that the quality of life was similarly increased in both groups. Patient satisfaction is significantly higher after MEA compared to TCRE. Both techniques led to a highly significant reduction in bleeding with a higher amenorrhoea rate after MEA (47%) than TCRE (41%). MEA was safer, quicker and easier to perform
Conclusion
This significant body of evidence from adequately powered, independent RCTs including the FDA Pivotal Study show that MEA is as effective as and faster than both gold standard first-generation ablation procedures and that MEA is acceptable for the vast majority of unselected women.
