Clean-study

This study hypothesized that the use of a degradable polymer film (WomedLeaf™) following radiofrequency endometrial ablation (EA) could reduce the formation of intrauterine adhesions (IUAs). IUAs are a common complication of EA and may lead to hematometra, post-ablation tubal sterilization syndrome, retrograde bleeding, and diagnostic challenges. While several anti-adhesion barriers have shown efficacy in preventing IUAs after hysteroscopic surgery, their effectiveness following thermal ablation techniques like radiofrequency (RF) remains unknown.

We conducted a multicenter, randomized, controlled, and blinded pilot trial at two Dutch hospitals between December 2022 and December 2023 to address this. Women aged ≥30 years with refractory heavy menstrual bleeding, eligible for EA with the Novasure® RF system, were included. After consent and intraoperative eligibility confirmation, participants were randomized 1:1 to either receive the WomedLeaf™ adhesion barrier film or no barrier. Exclusion criteria included uterine anomalies, prior IUA treatment, malignancies, infections, or known allergies to the film’s components.

The WomedLeaf™ film was inserted immediately following EA using a flexible 5-mm inserter and released intrauterine, unfolding to cover the endometrial surface. The film naturally degrades and is discharged within one week. Ultrasound was used to confirm positioning. All patients received standardized sedation and postoperative analgesia.

The primary outcome was IUA presence and severity, assessed via second-look hysteroscopy 4–6 weeks post-procedure. These were performed outpatient, without anaesthesia, by a blinded observer and recorded for external review. IUAs were categorized using the American Fertility Society (AFS) classification. Endometrial biopsies were obtained during the procedure for histopathological evaluation. After 3 months, participants were contacted by phone to assess bleeding (PBAC), dysmenorrhea (0–5 scale), satisfaction (0–5 scale), and adverse events.

These data provide insight into IUA formation after RF ablation and the potential of a polymer barrier film to reduce adhesion severity. They support future research on optimizing adhesion prevention strategies in endometrial ablation.