Treatment Failure After Laparoscopic Radiofrequency Ablation Compared With Myomectomy.

OBJECTIVE

To compare treatment failure and factors associated with failure between laparoscopic radiofrequency ablation (RFA) of leiomyomata and laparoscopic myomectomy.

METHODS

We analyzed data from the multicenter prospective ULTRA (Uterine Leiomyoma Treatment with Radiofrequency Ablation) study, which investigated laparoscopic RFA and laparoscopic myomectomy for symptomatic uterine leiomyomata. Our primary outcome was receipt of any subsequent procedure (surgical failure) for leiomyomata within 2 years of the procedure. Our secondary outcome was composite failure (surgical failure or any self-reported failure, eg, continued leiomyomata symptoms affecting quality of life) within 2 years of the procedure. Odds ratios (ORs) were generated from multivariable logit models adjusting for a priori selected covariates.

RESULTS

We identified significant baseline differences between our groups. The RFA group (n=231) was older and had higher body mass index (BMI), gravidity, and parity than the myomectomy group (n=110). In the RFA group, 15.2% experienced surgical failure compared with 3.8% in the myomectomy group (adjusted odds ratio [aOR] 4.17; 95% CI, 1.39-12.50), and 46.4% experienced composite failure in the RFA group compared with 25.5% in the myomectomy group (aOR 3.18; 95% CI, 1.80-5.60). Submucosal leiomyomata were associated with failure in the RFA group (OR 2.76; 95% CI, 1.21-6.28); there was a nonsignificant trend toward failure in the myomectomy group (OR 3.00; 95% CI, 0.99-9.05). Lateral leiomyomata were associated with higher odds of RFA failure (OR 2.49; 95% CI, 1.32-4.69), but no leiomyoma position was associated with myomectomy failure.

CONCLUSION

Laparoscopic RFA of leiomyomata is associated with higher odds of surgical and composite failure compared with laparoscopic myomectomy at 2 years, even after adjusting for baseline differences between groups.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02100904.