dysfunctional uterine bleeding & uterine fibroids - Health Plan of ...

Rosenbaum et al. (2005) evaluated HTEA in 47 premenopausal women with abnormal uterine
bleeding; 20 of these women had normal endometrial cavities and 27 had had intracavitary pathology,
most often leiomyomas. Follow-up ranged from 5 to 25 months with a mean of 12.7 months. Baseline
and follow-up scores were similar for both groups.
Radiofrequency Endometrial Ablation (RFA)
In two multicenter, 2-arm, randomized clinical trials, RFA, using the Vesta DUB or NovaSure
endometrial ablation devices, was compared with resection/rollerball ablation. RFA reduced mean
pictorial bleeding assessment chart (PBAC) scores from 535 (Corson, 2000) and 652 (Cooper, 2002) at
baseline to 18 and 27 at 1-year follow-up, respectively. This improvement was similar to that achieved
with resection/rollerball ablation. PBAC scores were reduced from 445 (Corson, 2000) and 562
(Cooper, 2002) to 28 and 36, respectively. The treatment was successful in 87% (Corson, 2000) and
91%of RFA patients compared with 83% (Corson , 2000) and 88% (Cooper , 2002) of
resection/rollerball ablation patients. Amenorrhea was achieved in 31% of RFA patients and 35% of
resection/rollerball ablation patients. The complication rate was similar for both procedures (2.2% and
13% for RFA; 3.5% and 25.3% for resection/rollerball ablation) but differed considerably between
studies. Differences in the devices, training and experience of the investigators, and the definition of
what constitutes a complication may account for some of these differences. Nevertheless, additional
studies may be needed to address the issue of procedure safety. At least one of these studies (Corson ,
2000) 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 resection/rollerball ablation
(Hayes, 2004).
Kleijn et al. (2008) previously reported that NovaSure was more effective than balloon ablation at 12
months follow up in the treatment of menorrhagia. In this follow-up study, the same authors report 5-
year outcomes. The objective was to evaluate amenorrhea rates, hysterectomy rate and quality of life
associated with the bipolar impedance-controlled endometrial ablation technique (NovaSure) in
comparison with balloon ablation technique (ThermaChoice) at 5 years after administration. A total of
126 premenopausal women with menorrhagia were randomly allocated to bipolar radio-frequency
ablation and balloon ablation in a 2:1 ratio. At 5 years of follow up, amenorrhea was reported in the
bipolar group by 48% of women and in the balloon arm by 32%. There were eight women in the
bipolar group (9.8%) and five in the balloon group (12.9%) who had undergone a hysterectomy.
Furthermore, there was a significant equal improvement of health-related QoL over time in both
groups. The authors concluded that, at 5 years follow up, bipolar thermal ablation was superior over
balloon ablation in the treatment of menorrhagia.
Bongers et al. (2004) compared the effectiveness of two second-generation ablation techniques, bipolar
radio-frequency impedance-controlled endometrial ablation (NovaSure) and balloon ablation
(ThermaChoice), in the treatment of menorrhagia. One hundred twenty-six women with menorrhagia,
without intracavitary abnormalities, were randomly allocated to bipolar radiofrequency ablation
(bipolar group) (n=83) and balloon ablation (balloon group) (n=43) in a 2:1 ratio. At follow up, both
women and observers were unaware of the type of treatment that had been performed. The main
outcome measure was amenorrhea at 3, 6 and 12 months after randomization. At the one-year follow
up stage, amenorrhea rates were 43% (34/83) in the bipolar group and 8% (3/43) in the balloon group.
At this stage, 90% of the patients in the bipolar group were satisfied with the result of the treatment
against 79% in the balloon group.
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