Ten-year follow-up of a randomised controlled
trial comparing bipolar endometrial ablation
with balloon ablation for heavy menstrual
MC Herman,aJPM Penninx,aBW Mol,a,bMY Bongersa
aDepartment of Obstetrics and Gynaecology, M? axima Medical Centre, Veldhoven, the NetherlandsbDepartment of Obstetrics and
Gynaecology, AMC Amsterdam, the Netherlands
Correspondence: Dr MC Herman, Department of Obstetrics and Gynecology, M? axima Medical Centre, PO Box 777, 5500 MB, Veldhoven,
the Netherlands. Email email@example.com
Accepted 11 February 2013. Published Online 21 March 2013.
Objective Previously, we have reported that, at both 12 months
and 5 years after treatment, bipolar endometrial ablation is
superior to balloon ablation in the treatment of heavy menstrual
bleeding. In this article, we evaluate the results at 10 years after
Design Ten-year follow-up of a double-blind
randomised controlled trial.
Setting A teaching hospital in the Netherlands.
Population Premenopausal women suffering from heavy
Method A follow-up questionnaire was sent to women 10 years
after randomisation for bipolar ablation and balloon ablation
(2 : 1 ratio).
Main outcome measures Amenorrhoea rates, re-intervention
and patient satisfaction.
Results At 10 years of follow-up, the response rate was
69/83 (83%) in the bipolar group and 35/43 (81%) in the
balloon group. Amenorrhoea rates were 50/69 (73%) in the
bipolar group and 23/35 (66%) in the balloon group
[relative risk, 1.1 (95% CI, 0.83–1.5)]. Further treatment
following initial ablation was reported in 21 cases, 14 in the
bipolar group and nine in the balloon group [relative risk, 0.9
(95% CI, 0.63–1.3)]. Eight of these women required further
treatment after 5 years, including two hysterectomies. Patient
satisfaction in the bipolar group was 81% (56/69) compared with
77% (27/35) in the balloon group [relative risk, 1.1 (95% CI,
Conclusion Ten years after treatment, the superiority of bipolar
ablation over balloon ablation in the treatment of heavy
menstrual bleeding was no longer evident.
Keywords Ablation, follow up, heavy menstrual bleeding, second-
Please cite this paper as: Herman M, Penninx J, Mol B, Bongers M. Ten-year follow-up of a randomised controlled trial comparing bipolar endometrial
ablation with balloon ablation for heavy menstrual bleeding. BJOG 2013;120:966–970.
Heavy menstrual bleeding (HMB) is a common gynaeco-
logical problem.1In 2004, we reported a randomised con-
(NovaSure®) and balloon ablation (Thermachoice®). The
primary outcome measure was amenorrhoea and the sec-
ondary outcome measures were patient satisfaction, re-
intervention and health-related quality of life (HRQoL).
This trial concluded that bipolar endometrial ablation was
more effective than balloon ablation in the treatment of
HMB within a follow-up of 12 months.2At 5 years of
follow-up, bipolar ablation remained superior to balloon
ablation.3In the present study, we report the effectiveness
of both treatments at 10 years after randomisation.
This report was based on a randomised controlled trial
comparing the bipolar radiofrequency impedance-con-
trolled endometrial ablation device (NovaSure) and the
thermal balloon ablation device (Thermachoice), which was
performed in the Maxima Medical Centre in the Nether-
lands between November 1999 and July 2001. This trial has
ª 2013 The Authors BJOG An International Journal of Obstetrics and Gynaecology ª 2013 RCOG