A 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) and radiofrequency nonresectoscopic endometrial ablation (EA) have similar risks of long-term reintervention for heavy menstrual bleeding (HMB), but the former has increased surgical reintervention risk, according to a recent study in the American Journal of Obstetrics & Gynecology.1
Takeaways
- Both the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) and radiofrequency nonresectoscopic endometrial ablation (RF NREA) have comparable long-term reintervention rates for treating heavy menstrual bleeding.
- Patients using the 52-mg LNG-IUS experienced a higher rate of surgical reinterventions (35.3%) compared to those undergoing RF NREA (19.1%).
- 25.9% of women in the LNG-IUS group required subsequent endometrial ablation, whereas no women in the RF NREA group needed this procedure.
- Hysterectomy rates were similar between the two groups, with 11.8% in the LNG-IUS group and 18.1% in the RF NREA group.
- Both treatments resulted in high rates of amenorrhea and patient satisfaction, with 95.1% and 97.8% achieving amenorrhea, and satisfaction rates of 74.0% and 84.4%, respectively, for LNG-IUS and RF NREA.
HMB, which is reported in approximately half of adult European women, significantly impacts patients’ quality of life (QOL). While LNG-IUS is considered a first-line treatment option, data has indicated discontinuation within 2 years among 39% of patients, suggesting a need for other treatment options.
Combined oral contraceptives have also been indicated as effective treatments for HMB, with similar EuroQol EQ-5D results to LNG-IUS.2 Similar major adverse events have also been found between treatment methods.
EA and hysterectomy are common surgical treatment options for patients with HMB.1 While hysterectomy is considered invasive and has a relatively long recovery time, EA has been proven both safe and effective.
To compare the safety and efficacy between a 52-mg LNG-IUS and radiofrequency nonresectoscopic EA, (RF NREA), investigators conducted a multicenter randomized controlled trial. Participants included women with a Pictorial Blood Loss Assessment Chart (PBAC) score above 150 points.
Patients aged under 34 years or those with desire to conceive, abnormal cervix cytology up to 5 years, intracavitary structures, substantial intramural fibroids, or a large uterus were excluded. Participants were randomized 1:1 to receive a 52-mg LNG-IUS or RF NREA.
The reintervention rate after long-term follow-up (FU) was measured as the primary outcome of the analysis, determined through responses to 6 online questionnaires. Surgical reinterventions included EA, hysterectomy, hysteroscopic or laparoscopic myomectomy, hysteroscopic adhesiolysis, and uterine fibroid embolization.
Drug interventions such as estrogen, progestogen, combined hormonal contraceptives, tranexamic acid, gonadotropin-releasing hormone analog, and antiprogestogen were also included in the primary outcome. Secondary outcomes included QOL, menstrual blood loss, menstrual pain indicators, spotting, amenorrhea, sexual function, and patient satisfaction.
There were 196 women aged a mean 53.2 years included in the final analysis. The mean FU duration among respondents was 7.4 years. A 52-mg LNG-IUS was given to 48% of women and an RF NREA to 52%. The mean age, FU duration, and treatment allocation did not significantly differ between groups.
A reintervention during the mean 7.4-year FU period was reported in 40% of the 52-mg LNG-IUS group vs 28.7% of the RF NREA group. The cumulative surgical reintervention rates in these groups were 35.3% and 19.1%, respectively.
Subsequent EA was reported in 25.9% of the 52-mg LNG-IUS group vs 0 women in the RF NREA group. However, hysterectomy rates were similar at 11.8% and 18.1%, respectively. There were 21 total reinterventions reported within 24 months, 12 in the 52-mg LNG-IUS group and 9 in the RF NREA group.
Both groups had a median PBAC score of 0, with only 1 woman reporting a persisting PBAC score over 150 points. Menstrual pattern indicators including dysmenorrhea and spotting also did not significantly differ between groups.
Rates of amenorrhea were 95.1% in the 52-mg LNG-IUS group and 97.8% in the RF NREA group. Rates of satisfaction were 74.0% and 84.4%, respectively.
These results indicated no differences in overall reintervention risk between treatment strategies, but increased risk of surgical reintervention among patients receiving 52-mg LNG-IUS. Investigators recommended counseling with patients to determine which treatment option is the most appropriate.
Reference
- Huijs DPC, Derickx AJM, Beelen P, et al. A 52-mg levonorgestrel-releasing intrauterine system vs bipolar radiofrequency nonresectoscopic endometrial ablation in women with heavy menstrual bleeding: long-term follow-up of a multicenter randomized controlled trial. Am J Obstet Gynecol. 2024;230:542.e1-10. doi:10.1016/j.ajog.2024.01.016
- Krewson C. Treating heavy menstrual bleeding: Levonorgestrel system vs combined oral contraceptives. Contemporary OB/GYN. November 8, 2023. Accessed May 22, 2024. https://www.contemporaryobgyn.net/view/treating-heavy-menstrual-bleeding-levonorgestrel-system-vs-combined-oral-contraceptives
