Efficacy of the silicone rubber uterine stent in the prevention of adhesion after hysteroscopic adhesiolysis: a prospective, randomized, controlled trial.

Background: Recurrent intrauterine adhesions (IUAs) after hysteroscopic adhesiolysis severely compromise fertility. This randomized trial investigated the efficacy of a pioneering silicone rubber uterine stent in preventing adhesion reformation. Methods: In a single-center, double-blind trial, 45 patients with moderate-to-severe IUAs underwent hysteroscopic adhesiolysis. The patients were randomized to receive a silicone rubber uterine stent (treatment group) or an auto-crosslinked hyaluronic acid gel. Intrauterine device (IUD) and 12-f Foley balloon catheter at the end of surgery (control group). All patients underwent second-look hysteroscopy at 2-3 months and hormonal therapy for two cycles after surgery. Pregnancies over 5 years were followed up. Results: Both groups had reduced American Fertility Society (AFS) scores postoperatively (P < 0.005), but the stent group achieved significantly greater reductions (P = 0.003). Severe IUA subgroup analyses revealed near-doubled AFS score improvements with stents versus controls (P = 0.023). The stent group demonstrated superior uterine cavity restoration, with markedly better involvement range scores (P < 0.05). The long-term data revealed that stent-treated patients had higher cumulative pregnancy rates (59.1% vs. 34.8%), with advantages emerging as early as 6 months post-surgery. Conclusion: Silicone uterine stents represent a breakthrough in preventing post-adhesiolysis IUAs, particularly for severe cases, offering enhanced anatomical recovery and fertility outcomes. This innovation addresses a critical unmet need in reproductive surgery, providing a robust strategy to safeguard fertility potential.