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

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.