dysfunctional uterine bleeding & uterine fibroids - Health Plan of ...
dysfunctional uterine bleeding & uterine fibroids - Health Plan of ...
dysfunctional uterine bleeding & uterine fibroids - Health Plan of ...
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WOU001<br />
Thermal balloon ablation was compared with RFA in 1 randomized, 2-arm clinical trial and in 1<br />
nonrandomized, multi-center, 2-arm trial (Abbott, 2003; Laberge, 2003). In these studies, treatment<br />
time was significantly shorter for RFA (3 to 4 minutes) compared with thermal balloon ablation (12 to<br />
23 minutes). At 12 months follow-up, RFA was effective in 96% <strong>of</strong> patients; 43% <strong>of</strong> patients<br />
developed amenorrhea, 27% hypomenorrhea, and 16% eumenorrhea (Abbott, 2003).<br />
Thermal balloon ablation was effective in 100% <strong>of</strong> patients; 12% <strong>of</strong> patients developed amenorrhea,<br />
59% hypomenorrhea, and 29% eumenorrhea. RFA caused less intra- and postoperative pain compared<br />
with thermal balloon ablation (Laberge, 2003). The Abbott study had the statistical power to detect a<br />
20% difference in efficacy based on the PBAC scores. The results therefore suggest that the efficacy <strong>of</strong><br />
RFA compares to that <strong>of</strong> thermal balloon ablation.<br />
A National Institute for <strong>Health</strong> and Clinical Excellence (NICE) guidance document states that while<br />
information is lacking about the long-term results <strong>of</strong> the procedure, current evidence on the safety and<br />
efficacy <strong>of</strong> impedance-controlled bipolar radi<strong>of</strong>requency ablation for menorrhagia appears adequate to<br />
support the use <strong>of</strong> this procedure, provided that the normal arrangements are in place for consent, audit<br />
and clinical governance (NICE, 2004).<br />
Microwave Endometrial Ablation (MEA)<br />
In a systematic review, Garside et al. (2005) compared the effectiveness <strong>of</strong> microwave and thermal<br />
balloon endometrial ablation with first generation techniques <strong>of</strong> endometrial ablation to treat heavy<br />
menstrual <strong>bleeding</strong> in women. Two randomized controlled trials <strong>of</strong> microwave endometrial ablation<br />
and eight trials (six randomized controlled trials) <strong>of</strong> thermal balloon endometrial ablation were<br />
included in the review. No significant differences were found between first and second generation<br />
techniques in terms <strong>of</strong> amenorrhoea, <strong>bleeding</strong> patterns, premenstrual symptoms, patient satisfaction or<br />
quality <strong>of</strong> life. Microwave endometrial ablation and thermal balloon endometrial ablation had<br />
significantly shorter operating times than first generation techniques. Adverse effects were few with all<br />
techniques, but there were fewer peri-operative adverse effects with second generation techniques.<br />
Cooper et al. (2004) compared the effectiveness, safety and acceptability <strong>of</strong> microwave endometrial<br />
ablation (MEA) with those <strong>of</strong> rollerball electroablation (REA) for the treatment <strong>of</strong> menorrhagia. Three<br />
hundred twenty-two women with documented menorrhagia due to benign causes were randomized to<br />
either MEA or REA in a 2:1 allocation scheme. Of the 215 patients in the MEA group, 209 were<br />
treated, with 194 available for evaluation at 1 year. Of the 107 patients in the REA group, 106 were<br />
treated, with 96 available for evaluation at 1 year. The success rate <strong>of</strong> MEA at 12 months did not differ<br />
significantly from that <strong>of</strong> REA. The amenorrhea rate in evaluable patients after MEA was 61.3% and<br />
51% after REA. Patient satisfaction with results <strong>of</strong> treatment was high (98.5% <strong>of</strong> the MEA and 99.0%<br />
<strong>of</strong> the REA group). The authors concluded that MEA is an efficacious and safe procedure for the<br />
treatment <strong>of</strong> menorrhagia and is suitable for women with myomas and irregular <strong>uterine</strong> cavities.<br />
Cooper, et al. (1999) conducted a randomized controlled trial, comparing microwave endometrial<br />
ablation (MEA) with transcervical resection <strong>of</strong> the endometrium (TCRE), for women with heavy<br />
menstrual loss. Two hundred sixty three women were randomly assigned to MEA (n=129) or TCRE<br />
(n=134). Questionnaires were completed at recruitment and at 12 months' follow-up. The primary<br />
outcome measures were patients' satisfaction with and the acceptability <strong>of</strong> treatment. At 1 year <strong>of</strong><br />
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