Microwave endometrial ablation versus thermal balloon endometrial ablation (MEATBall): 5-year follow up of a randomised controlled trial

Abstract

Objective: To compare long-term outcomes following microwave endometrial ablation (MEA™) and thermal balloon ablation (TBall).

Design: Follow up of a prospective, double-blind randomised controlled trial at 5 years.

Setting: A teaching hospital in the UK.

Population: A total of 320 women eligible for and requesting endometrial ablation.

Methods: Eligible women were randomised in a 1:1 ratio to undergo MEA or Tball. Postal questionnaires were sent to participants at a minimum of 5 years postoperatively to determine satisfaction with outcome, menstrual status, bleeding scores and quality of life measurement. Subsequent surgery was ascertained from the women and the hospital operative database.

Main outcome measures: The primary outcome measure was overall satisfaction with treatment. Secondary outcomes included evaluation of menstrual loss, change in quality of life scores and subsequent surgery.

Results: Of the women originally randomised 217/314 (69.1%) returned questionnaires. Nonresponders were assumed to be treatment failures for data analysis. The primary outcome of satisfaction was similar in both groups (58% for MEA™ versus 53% for TBall, difference 5%; 95% CI -6 to 16%). Amenorrhoea rates were high following both techniques (51% versus 45%, difference 6%; 95% CI -5 to 17%). There was no significant difference in the hysterectomy rates between the two arms (9% versus 7%, difference 2%; 95% CI -5 to 9%).

Conclusions: At 5 years post-treatment there were no significant clinical differences in patient satisfaction, menstrual status, quality of life scores or hysterectomy rates between MEA™ and Thermachoice 3, thermal balloon ablation.

Keywords: Endometrial ablation; heavy menstrual bleeding; long-term follow up; randomised controlled trial.