Safety and effectiveness of an in situ-forming hydrogel barrier in preventing intrauterine adhesions after adhesiogenic hysteroscopic procedures: a multicenter, randomized, controlled trial

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OBJECTIVE: To evaluate the safety and effectiveness of an in situ-forming intrauterine hydrogel barrier compared with no barrier in preventing intrauterine adhesions after adhesiogenic hysteroscopic surgery, and to assess changes in adhesion severity in the adhesiolysis cohort. DESIGN: Randomized, multicenter, subject- and evaluator-blinded trial conducted across 15 U.S. SUBJECTS: Premenopausal women ≥18 years undergoing hysteroscopic adhesiolysis for moderate to severe intrauterine adhesions or hysteroscopic myomectomy for International Federation of Gynecology and Obstetrics (FIGO) Type 1 or 2 leiomyomas ≥1 cm, considered at risk for postoperative adhesions. INTERVENTION: After completion of the index procedure, participants were randomized 2:1 to receive an in situ-forming intrauterine hydrogel barrier (‟spacer") or no barrier. MAIN OUTCOME MEASURES: The primary endpoint was the proportion of participants without intrauterine adhesions at second-look hysteroscopy, as assessed by a blinded, independent central review committee using paired video evaluation. Change in adhesion severity from baseline to second-look hysteroscopy was a secondary endpoint. Safety outcomes included device and/or procedure-related adverse events from the time of randomization through 3 weeks after the index procedure. RESULTS: Between August 2022 and January 2025, 150 participants were randomized (hydrogel barrier: n = 99; control: n = 51). In the intention-to-treat analysis, a greater proportion of hydrogel participants were adhesion-free at second-look than controls (68.7% vs. 51.4%). In the adhesiolysis subgroup (n = 102), more participants in the hydrogel barrier arm were adhesion-free compared with controls (60.3% vs. 32.3%; odds ratio [OR] 3.19, 95% confidence interval [CI]: 1.29-7.90), and adhesion severity was reduced (6.3% vs. 32.3%; OR 0.14, 95% CI: 0.04-0.50). In the leiomyoma subgroup (n = 48), adhesion rates were 16.7% in the hydrogel group and 21.4% in controls; however, the estimated treatment effect was imprecise because of the limited subgroup sample size and wide CI (OR 0.73, 95% CI: 0.15-3.62). No serious device-related adverse events were observed. CONCLUSION: In this multicenter randomized trial, use of an in situ-forming intrauterine hydrogel barrier with a 2- to 3-week residence time after adhesiogenic hysteroscopic procedures increased the proportion of participants without intrauterine adhesions at second-look hysteroscopy compared with no intrauterine barrier. In subgroup analyses, the benefit was largely confined to participants undergoing adhesiolysis. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05394662. Date of registration: 2022-05-24.

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