Abstract
Objective
To compare the effectiveness of bipolar radiofrequency (Novasure®) ablation and balloon endometrial ablation (Thermablate®).
Study design
We performed a multi-center double blind, randomized controlled trial in three hospitals
in The Netherlands. Women with heavy menstrual bleeding were randomly allocated to
bipolar or balloon endometrial ablation, performed in the office, using a paracervical
block. The primary outcome was amenorrhea. Secondary outcome measures were pain, satisfaction,
quality of life and reintervention.
Results
104 women were randomized into the bipolar (52) and balloon (52) groups. After 12
months amenorrhea rates were 56% (29/52) in the bipolar group and 23% (12/52) in the
balloon group (relative risk (RR) 0.6, 95% confidence interval (CI) 0.4–0.8). The
mean visual analog pain score of the total procedure was 7.1 in the bipolar group
and 7.4 in the balloon group (P < .577). 87% (45/52) of the patients in the bipolar group were satisfied with the result
of the treatment versus 69% (36/52) in the balloon group (RR 0.44, 95% CI 0.2–0.97).
The reintervention rates were 5/52 (10%) in the bipolar group and 6/52 (12%) in the
balloon group (RR 1.02, 95% CI 0.9–1.2). Quality of life (Shaw score) improved over
time (P < .001) and was significantly higher in the bipolar group at 12 months follow-up (P = .025).
Conclusion
In the treatment of heavy menstrual bleeding, bipolar radiofrequency endometrial ablation
is superior to balloon endometrial ablation as an office procedure in amenorrhea rate,
patient satisfaction and quality of life.
Keywords
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Article info
Publication history
Published online: October 24, 2015
Accepted:
October 15,
2015
Received in revised form:
September 30,
2015
Received:
June 6,
2015
Identification
Copyright
© 2015 Published by Elsevier Inc.
