LAS VEGAS — Bipolar radiofrequency ablation and thermal balloon ablation are equally effective for the treatment of menorrhagia, a population-based cohort study showed.
However, women who underwent radiofrequency ablation (RFA, or NovaSure), a technology that was introduced in 2001, were nearly three times more likely to develop postprocedural amenorrhea than were women who underwent thermal balloon ablation (TBA, or ThermaChoice), a technology that was introduced in 1997, Dr. Sherif El-Nashar said at the annual meeting of the AAGL.
“In several randomized clinical trials, the newer global endometrial ablation technologies had comparable efficacy to hysteroscopic endometrial ablation, along with [an] improved safety profile,” said Dr. El-Nashar of the department of obstetrics and gynecology at the Mayo Clinic, Rochester, Minn.
“Despite the wide use of global endometrial ablation technologies in clinical practice, to date, only two randomized controlled trials have directly compared RFA and TBA technologies. Despite their excellent design, they had relatively small sample sizes, were all from single centers, and had a relatively short follow-up,” he added.
In a study led by Dr. El-Nashar's mentor, Dr. Abimbola O. Famuyide, the researchers used the Rochester Epidemiology Project to identify 455 women who resided in Olmsted County, Minn., and underwent global endometrial ablation for menorrhagia between January 1998 and December 2005. The project includes information about patients receiving care at Olmsted Medical Center and the Mayo Clinic.
The researchers then compared the efficacy of RFA to TBA using treatment failure and postprocedure amenorrhea as outcome measures. Treatment failure was defined as reablation or hysterectomy for persistent bleeding or pain; amenorrhea was defined as the complete cessation of menstruation starting immediately post ablation for 12 months or more.
Of the 455 patients, 255 underwent RFA and 200 underwent TBA; both groups were followed for a median of 2.2 years. The patients' average age was 43, and their mean body mass index was 29 kg/m
Dr. El-Nashar reported that there were no significant differences in the time to treatment failure between the two groups, with a 3-year cumulative failure rate of 9% in the RFA group, compared with 12% in the TBA group. This difference remained nonsignificant after adjustment for known predictors of treatment failure including age, parity, pretreatment dysmenorrhea, and tubal ligation.
However, women in the RFA group had significantly higher amenorrhea rates, compared with their counterparts in the TBA group (32% vs. 14%). This difference remained significant after adjustment for known predictors of amenorrhea including age, uterine length, and endometrial thickness (adjusted odds ratio, 2.9).
Complications were infrequent and comparable in the two groups.
Dr. El-Nashar said he had no conflicts of interest to disclose.
The RFA and TBA groups displayed no significant differences in the time to treatment failure. DR. EL-NASHAR