Hysteroscopic fundal fixation of LNG-IUS in adenomyosis: a prospective feasibility and safety study.

BACKGROUND

Expulsion of the levonorgestrel-releasing intrauterine system (LNG-IUS) limits its effectiveness in adenomyosis management, particularly in patients with anatomical risk factors. This study aimed to assess the feasibility and short-term safety of a novel hysteroscopic fixation technique designed to improve device retention.

METHODS

In this single-center prospective feasibility study, 52 patients with adenomyosis underwent placement of a modified LNG-IUS (integrated with a GyneFix anchor) using a customized delivery cannula under hysteroscopic guidance. Feasibility outcomes included successful device deployment and procedural time. Safety outcomes included intraoperative complications, device expulsion rate at 6 months (exploratory), and adverse events. Symptom changes (pain VAS, menstrual PBAC scores) were assessed as exploratory endpoints.

RESULTS

The procedure was successfully completed in all 52 patients (100%) with a mean operative time of 23.9 ± 8.1 min. No intraoperative complications occurred. During the 6-month follow-up, no device expulsions were observed (0%; 95% CI: 0–6.8%). Symptom assessments indicated reductions in median pain VAS scores (from 7.2 to 2.8) and PBAC scores. Irregular bleeding was common initially, persisting as light spotting in 18 patients (34.6%) at 6 months.

CONCLUSIONS

This feasibility study suggests that the novel fundal fixation technique is technically achievable and appears safe in the short term for patients with adenomyosis who have completed childbearing. The observed device retention rate is encouraging, but requires confirmation in larger comparative studies with longer follow-up.