Treatment of Severe and Moderate Intrauterine Adhesions: Results of PREG2 International RCT on the Effectiveness of Womed Leaf Barrier Film

IF 3.5 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Journal of minimally invasive gynecology Pub Date : 2024-11-01 DOI:10.1016/j.jmig.2024.09.095

H Fernandez , L Miquel , J Sroussi , S Weyers , M Munmany , X Luo , P Kovar , Y Wang , A Sardo Di Spiezio , A Surbonne , V Delporte , E Moratalla , M Sauvan , G Perrini , L Sui , M Mara

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引用次数: 0

Abstract

Study Objective

Recurrence rate after hysteroscopic adhesiolysis can be as high as 60%. This RCT aimed to assess the effectiveness of a new intrauterine mechanical barrier film in the management of IUA.

Design

PREG2 is a double-blind randomized, controlled, stratified study.

Setting

16 sites in Europe and China.

Patients or Participants

Patients scheduled for hysteroscopic adhesiolysis because of symptomatic severe or moderate adhesions (AFS score ≥ 5).

Interventions

Following adhesiolysis, patients were randomized to either have a Womed Leaf film inserted or not. Womed Leaf (Womed SAS, France) is a degradable polymer film that expands to fill the entire cavity and acts as a mechanical barrier between the uterine walls. After about a week, it degrades and is discharged naturally. Hormonal treatment was authorized in both groups. Patients were scheduled for second-look hysteroscopy (SLH) after 4 to 8 weeks.

Measurements and Main Results

The effectiveness endpoints were: Change in AFS score between baseline and SLH, responder rate (i.e. patients who improved of at least two clinical categories, e.g. from severe to mild or from moderate to no IUA) and absence of IUA at SLH. The patient and the SLH evaluator were blind. 160 women were randomized. The reduction in AFS score at SLH was significantly higher in the intervention compared to the control group (5.2 ± 2.8 vs. 4.2 ± 3.2; p=0.0153). The responder rate was significantly higher in the intervention group (51% vs 29% OR 2.7 [1.4–5.5]; p=0.0052). The absence of adhesions at SLH was significantly higher in the intervention group (41% vs 24% OR 2.44 [CI 1.161 - 5.116]; p=0.0189). None of the reported adverse events were serious or considered related to the device.

Conclusion

This large RCT of patients with severe or moderate IUA demonstrated the effectiveness of Womed Leaf. It is the first adhesion barrier to show any clinically meaningful improvement in this challenging indication.

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治疗重度和中度宫内粘连：关于沃麦德叶片屏障膜疗效的 PREG2 国际临床试验结果

研究目的宫腔镜粘连分解术后的复发率可高达60%。这项研究旨在评估一种新型宫腔内机械屏障膜在治疗 IUA 方面的有效性。设计PREG2 是一项双盲随机对照分层研究。患者或参与者因无症状的重度或中度粘连（AFS 评分≥ 5 分）而计划接受宫腔镜粘连溶解术的患者。干预措施粘连溶解术后，患者被随机分配是否植入 Womed Leaf 膜。Womed Leaf（Womed SAS，法国）是一种可降解的聚合物薄膜，可膨胀以填充整个宫腔，在子宫壁之间起到机械屏障的作用。大约一周后，它就会降解并自然排出。两组患者都接受了激素治疗。患者将在 4 至 8 周后接受宫腔镜二次检查（SLH）：疗效终点为：基线与 SLH 之间 AFS 评分的变化、应答率（即至少两个临床类别得到改善的患者，如从重度到轻度或从中度到无 IUA）以及 SLH 时无 IUA。患者和 SLH 评估人员均为盲人。160 名妇女被随机选中。与对照组相比，干预组在SLH时的AFS评分降低幅度明显更高（5.2 ± 2.8 vs. 4.2 ± 3.2；P=0.0153）。干预组的应答率明显更高（51% vs 29% OR 2.7 [1.4-5.5]; p=0.0052）。干预组腹腔镜下无粘连率明显更高（41% vs 24% OR 2.44 [CI 1.161 - 5.116]；P=0.0189）。结论这项针对重度或中度 IUA 患者的大型 RCT 证明了 Womed Leaf 的有效性。它是首个在这一具有挑战性的适应症中显示出有临床意义的改善的粘连屏障。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of minimally invasive gynecology 医学-妇产科学

CiteScore

5.00

自引率

7.30%

发文量

272

审稿时长

37 days

期刊介绍： The Journal of Minimally Invasive Gynecology, formerly titled The Journal of the American Association of Gynecologic Laparoscopists, is an international clinical forum for the exchange and dissemination of ideas, findings and techniques relevant to gynecologic endoscopy and other minimally invasive procedures. The Journal, which presents research, clinical opinions and case reports from the brightest minds in gynecologic surgery, is an authoritative source informing practicing physicians of the latest, cutting-edge developments occurring in this emerging field.