Levonorgestrel Intrauterine Device versus Combined Transcervical Resection of the Endometrium in the Management of Adenomyosis: A Randomized Clinical Trial.

Abstract

Objectives: To compare the treatment failure rates in patients with adenomyosis who underwent transcervical resection of the endometrium (TCRE) and levonorgestrel intrauterine device (LNG-IUD) insertion versus those with LNG-IUD insertion alone.

Materials and methods: One hundred and forty-six women with adenomyosis and heavy menstrual bleeding (HMB) or dysmenorrhea were enrolled in this randomized controlled clinical trial (CTRI/2020/09/027592). One group had TCRE with LNG-IUD insertion and the other group had only LNG-IUD insertion. Baseline assessment included quality of life score (World Health Organisation quality of life-BREF [WHO QOL-BREF]), and menorrhagia multi-attribute scale (MMAS) score. The patients in both the treatment arms were followed up for 12 months. The scores were reassessed at 12 months along with LNG-IUD expulsion rates and treatment failure, which included any of the following: hysterectomy for adenomyosis, persistent HMB, or persistent dysmenorrhea.

Results: The primary outcome of treatment failure was significantly lower in the TCRE + LNG-IUD group (7.14% vs. 25%, P = 0.01; Risk ratio 3.45, 95% Confidence interval (1.35-8.83). The quality-of-life (WHO QOL-BREF) and MMAS scores at 12 months were also significantly better in the TCRE + LNG-IUD arm. None of the women in the combined TCRE and LNG-IUD group had LNG-IUD expulsion at 12 months compared to the LNG-IUD expulsion rate of 8.8% in the LNG-IUD alone group (P = 0.013).

Conclusion: A combination of TCRE with LNG-IUD had a lower failure rate at 12 months in women with adenomyosis compared to LNG-IUD alone. This combination also resulted in better quality of life and lowered the chance of LNG-IUD expulsion at 12 months.