Department of Obstetrics & Gynecology, Scripps Clinic, San Diego, California; Division of Women's Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama; the Institute for Female Pelvic Medicine & Reconstructive Surgery, North Wales, Pennsylvania; the Department of Obstetrics and Gynecology, University of Chicago Pritzker School of Medicine, Chicago, and the Division of Urogynecology, Department of Obstetrics and Gynecology, NorthShore University HealthSystem, Winnetka, Illinois; the American Association of Female Pelvic Medicine Specialists, Inc., Westlake Village, California; the, Department of Family Medicine, University of Southern California, Westlake Village, California; the Division of Female Pelvic Medicine & Reconstructive Surgery, Department of Obstetrics and Gynecology, Cooper University Health Care, Cooper Medical School of Rowan University, Camden, New Jersey; the Department of Urology, Columbia University Irving Medical Center, New York, New York; the Department of Urology, West Chester Hospital, West Chester Township, and the Division of Urology, Department of Surgery, University of Cincinnati College of Medicine Cincinnati, Ohio; and Division of Urogynecology and Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics & Gynecology, School of Medicine, University of California, Irvine, Orange, California.
Obstet Gynecol. 2022 Jun 1;139(6):975-985. doi: 10.1097/AOG.0000000000004794. Epub 2022 May 2.
To compare the safety and effectiveness of transvaginal mesh repair and native tissue repair, in response to a U.S. Food and Drug Administration (FDA) 522 study order to assess co-primary endpoints of superiority and noninferiority.
This was a prospective, nonrandomized, parallel cohort, multi-center trial comparing transvaginal mesh with native tissue repair for the treatment of pelvic organ prolapse. The primary endpoints were composite treatment success at 36 months comprised of anatomical success (defined as pelvic organ prolapse quantification [POP-Q] point Ba≤0 and/or C≤0), subjective success (vaginal bulging per the PFDI-20 [Pelvic Floor Distress Inventory]), and retreatment measures, as well as rates of serious device-related or serious procedure-related adverse events. Secondary endpoints included a composite outcome similar to the primary composite outcome but with anatomical success defined as POP-Q point Ba<0 and/or C<0, quality-of-life measures, mesh exposure and mesh- and procedure-related complications. Propensity score stratification was applied.
Primary endpoint composite success at 36 months was 89.3% (201/225) for transvaginal mesh and 80.2% (389/485) for native tissue repair, demonstrating noninferiority at the preset margin of 12% (propensity score-adjusted treatment difference 6.5%, 90% CI -0.2% to 13.2%). Using the primary composite endpoint, transvaginal mesh was not superior to native tissue repair (P=.056). Using the secondary composite endpoint, superiority of transvaginal mesh over native tissue repair was noted (P=.009), with a propensity score-adjusted difference of 10.6% (90% CI 3.3-17.9%) in favor of transvaginal mesh. Subjective success for both the primary and secondary endpoint was 92.4% for transvaginal mesh, 92.8% for native tissue repair, a propensity score-adjusted difference of -4.3% (CI -12.3% to 3.8%). For the primary safety endpoint, 3.1% (7/225) of patients in the transvaginal mesh (TVM) group and 2.7% (13/485) of patients in the native tissue repair (NTR) group developed serious adverse events, demonstrating that transvaginal mesh was noninferior to native tissue repair (-0.4%, 90% CI -2.7% to 1.9%). Overall device-related and/or procedure-related adverse event rates were 35.1% (79/225) in the TVM group and 46.4% (225/485) in the NTR group (-15.7%, 95% CI -24.0% to -7.5%).
Transvaginal mesh repair for the treatment of anterior and/or apical vaginal prolapse was not superior to native tissue repair at 36 months. Subjective success, an important consideration from the patient-experience perspective, was high and not statistically different between groups. Transvaginal mesh repair was as safe as native tissue repair with respect to serious device-related and/or serious procedure-related adverse events.
This study was sponsored by Boston Scientific and developed in collaboration with FDA personnel from the Office of Surveillance and Biometrics, Division of Epidemiology.
ClinicalTrials.gov, NCT01917968.
根据美国食品和药物管理局（FDA）522 研究命令，评估主要终点的优越性和非劣效性，比较经阴道网片修复与天然组织修复的安全性和有效性。
这是一项前瞻性、非随机、平行队列、多中心试验，比较经阴道网片与天然组织修复治疗盆腔器官脱垂。主要终点是 36 个月时复合治疗成功率，包括解剖学成功率（定义为盆腔器官脱垂定量[POP-Q]点 Ba≤0 和/或 C≤0）、主观成功率（PFDI-20[盆腔窘迫量表]阴道膨出）和补救治疗措施，以及严重器械相关或严重手术相关不良事件的发生率。次要终点包括与主要复合结局相似的复合结局，但解剖学成功率定义为 POP-Q 点 Ba<0 和/或 C<0、生活质量测量、网片暴露和网片及手术相关并发症。应用倾向评分分层。
36 个月时经阴道网片组复合成功率为 89.3%（201/225），天然组织修复组为 80.2%（389/485），在预设的 12%（倾向评分调整治疗差异 6.5%，90%CI-0.2%至 13.2%）边界内显示非劣效性。使用主要复合终点，经阴道网片并不优于天然组织修复（P=.056）。使用次要复合终点，经阴道网片优于天然组织修复（P=.009），经阴道网片的优势为 10.6%（90%CI 3.3-17.9%）。主要和次要终点的主观成功率分别为经阴道网片组 92.4%，天然组织修复组 92.8%，经阴道网片组的差异为-4.3%（CI-12.3%至 3.8%）。对于主要安全性终点，经阴道网片组 3.1%（7/225）的患者和天然组织修复组 2.7%（13/485）的患者发生严重不良事件，表明经阴道网片不劣于天然组织修复（-0.4%，90%CI-2.7%至 1.9%）。经阴道网片组的总器械相关和/或手术相关不良事件发生率为 35.1%（79/225），天然组织修复组为 46.4%（225/485）（-15.7%，95%CI-24.0%至-7.5%）。
36 个月时，经阴道网片修复治疗前壁和/或顶壁阴道脱垂并不优于天然组织修复。主观成功率（从患者体验的角度来看是一个重要的考虑因素）较高，且两组间无统计学差异。经阴道网片修复与天然组织修复的严重器械相关和/或严重手术相关不良事件发生率相当。
本研究由波士顿科学公司赞助，并与 FDA 人员合作开发，来自监测和生物统计学办公室，流行病学司。
ClinicalTrials.gov，NCT01917968。
