Bipolar radiofrequency compared with thermal balloon ablation in the office: a randomized controlled trial.

OBJECTIVE

To estimate the effectiveness of office-based bipolar radiofrequency ablation compared with thermal balloon ablation of the endometrium for the treatment of heavy menstrual bleeding at 5-year follow-up.

METHODS

A single blind randomized controlled trial was conducted in an office hysteroscopy clinic in a university teaching hospital. A total of 81 women were randomly allocated to either bipolar radiofrequency ablation or thermal balloon ablation in an office setting avoiding use of general anesthesia or conscious sedation. The primary outcome for the trial was amenorrhea at 6 months follow-up. In this planned secondary analysis, the main outcome measures were amenorrhea rates, patient satisfaction, health-related quality of life, and incidence of further uterine surgery at 5-year follow-up.

RESULTS

At 5-year follow-up, 59 (73%) women responded to postal questionnaires. Amenorrhea was reported in 60% of thermal balloon ablation and 62% of bipolar radiofrequency ablation (odds ratio [OR] 1.09 [0.38-3.11]) and satisfaction with treatment outcome in 96% of thermal balloon ablation and 96% of bipolar radiofrequency ablation (OR 0.92 [0.05-25.59]). Further surgical intervention was needed in three of 29 (10%) women treated with bipolar radiofrequency ablation compared with four of 30 (13%) of women treated with thermal balloon ablation (P=.7). There was no significant difference in either condition-specific or generic health-related quality-of-life measures.

CONCLUSION

There was no difference in the effectiveness of bipolar radiofrequency ablation and thermal balloon ablation performed in an office setting at 5-year follow-up.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, www.clinicaltrials.gov, NCT01124357.

LEVEL OF EVIDENCE

I.