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Thermal balloon ablation was compared with RFA in 1 randomized, 2-arm clinical trial and in 1
nonrandomized, multi-center, 2-arm trial (Abbott, 2003; Laberge, 2003). In these studies, treatment
time was significantly shorter for RFA (3 to 4 minutes) compared with thermal balloon ablation (12 to
23 minutes). At 12 months follow-up, RFA was effective in 96% of patients; 43% of patients
developed amenorrhea, 27% hypomenorrhea, and 16% eumenorrhea (Abbott, 2003).
Thermal balloon ablation was effective in 100% of patients; 12% of patients developed amenorrhea,
59% hypomenorrhea, and 29% eumenorrhea. RFA caused less intra- and postoperative pain compared
with thermal balloon ablation (Laberge, 2003). The Abbott study had the statistical power to detect a
20% difference in efficacy based on the PBAC scores. The results therefore suggest that the efficacy of
RFA compares to that of thermal balloon ablation.
A National Institute for Health and Clinical Excellence (NICE) guidance document states that while
information is lacking about the long-term results of the procedure, current evidence on the safety and
efficacy of impedance-controlled bipolar radiofrequency ablation for menorrhagia appears adequate to
support the use of this procedure, provided that the normal arrangements are in place for consent, audit
and clinical governance (NICE, 2004).
Microwave Endometrial Ablation (MEA)
In a systematic review, Garside et al. (2005) compared the effectiveness of microwave and thermal
balloon endometrial ablation with first generation techniques of endometrial ablation to treat heavy
menstrual bleeding in women. Two randomized controlled trials of microwave endometrial ablation
and eight trials (six randomized controlled trials) of thermal balloon endometrial ablation were
included in the review. No significant differences were found between first and second generation
techniques in terms of amenorrhoea, bleeding patterns, premenstrual symptoms, patient satisfaction or
quality of life. Microwave endometrial ablation and thermal balloon endometrial ablation had
significantly shorter operating times than first generation techniques. Adverse effects were few with all
techniques, but there were fewer peri-operative adverse effects with second generation techniques.
Cooper et al. (2004) compared the effectiveness, safety and acceptability of microwave endometrial
ablation (MEA) with those of rollerball electroablation (REA) for the treatment of menorrhagia. Three
hundred twenty-two women with documented menorrhagia due to benign causes were randomized to
either MEA or REA in a 2:1 allocation scheme. Of the 215 patients in the MEA group, 209 were
treated, with 194 available for evaluation at 1 year. Of the 107 patients in the REA group, 106 were
treated, with 96 available for evaluation at 1 year. The success rate of MEA at 12 months did not differ
significantly from that of REA. The amenorrhea rate in evaluable patients after MEA was 61.3% and
51% after REA. Patient satisfaction with results of treatment was high (98.5% of the MEA and 99.0%
of the REA group). The authors concluded that MEA is an efficacious and safe procedure for the
treatment of menorrhagia and is suitable for women with myomas and irregular uterine cavities.
Cooper, et al. (1999) conducted a randomized controlled trial, comparing microwave endometrial
ablation (MEA) with transcervical resection of the endometrium (TCRE), for women with heavy
menstrual loss. Two hundred sixty three women were randomly assigned to MEA (n=129) or TCRE
(n=134). Questionnaires were completed at recruitment and at 12 months' follow-up. The primary
outcome measures were patients' satisfaction with and the acceptability of treatment. At 1 year of
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