A novel intrauterine estrogen-releasing system for preventing the postoperative recurrence of intrauterine adhesion: a multicenter randomized controlled study

A novel intrauterine estrogen-releasing system for preventing the postoperative recurrence of intrauterine adhesion: a multicenter randomized controlled study

Background

Previous studies have shown that postoperative oral estrogen or an intrauterine physical barrier could reduce the recurrence of intrauterine adhesion (IUA). Our team designed an intrauterine stent that slowly releases estrogen within the uterine cavity. In this study, we aimed to investigate the efficacy and safety of the estrogen-releasing intrauterine system in preventing the recurrence of moderate to severe IUA.

Methods

This was a multicenter prospective randomized controlled 2-arm parallel trial that included patients diagnosed with moderate to severe IUA and who received transcervical resection of adhesions (TCRA). A total of 250 patients were randomly assigned to receive the intrauterine estrogen-releasing system or a Foley catheter balloon combined with oral estrogen therapy after surgery.

Results

At 60 days postoperatively, the rate of adhesion reduction was significantly greater in the experimental group than in the control group (93.33% vs. 58.56%, p < 0.001). The endometrium of the experimental group was thicker than that of the control group (p < 0.001). The rate of improvement in menstruation was also greater in the experimental group than in the control group (p = 0.010). No severe adverse events were found in either group during the 1-year follow-up.

Conclusions

In patients with moderate to severe IUA, the intrauterine estrogen-releasing system was more effective at reducing adhesion than traditional oral estrogen combined with an intrauterine Foley catheter after TCRA. This novel intrauterine system provides a new option for the management of IUA after surgery.

TRIAL REGISTRATION: The registration number is NCT04972032. Date of registration: August 15, 2021.

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