Pietak Patrycja, Futyma Konrad, Rechberger-Krolikowska Ewa, Struzyk Aleksandra, Kolodynska Aleksandra, Rechberger Tomasz
II Department of Gynecology; Medical University of Lublin, Poland, Poland.
Ginekol Pol. 2025;96(7):542-552. doi: 10.5603/gpl.104105. Epub 2025 May 26.
The aim of the study was to investigate how surgical management strategies for pelvic organ prolapse (POP) have changed in a single-centre department over the last decade, as Food and Drug Administration (FDA) warnings have changed worldwide attitudes to mesh augmented reconstruction.
The study group consisted of 4180 patients who were operated on due to advanced symptomatic POP (≥ 2 POP-Q scale) from January 2010 to December 2020. Patients were divided into three groups depending on the type of POP vaginal surgery performed: group 1 - vaginal native tissue repair (VNTR) - (n = 1376); group 2 - transvaginal mesh repair (TVM; anterior, posterior, or both) - (n = 2494), and group 3 - transvaginal hysterectomy (TVH) - (n = 310). The clinical effectiveness of each type of procedure was estimated by means of the NIH Pelvic Floor Disorders Network criteria.
The number of VNTR surgeries has significantly increased since 2017, following FDA warnings about the safety of these surgeries. The reoperation rate during the follow-up period did not differ between the investigated groups. However, urgency occurrence was significantly lower in the VNTR group when compared to the TVM and TVH groups (p < 0.05).
In most cases of symptomatic POP, vaginal native tissue repair is a safe and effective primary treatment. Based on the reoperation rate and the functional outcome we have not found any evidence of benefits from augmenting surgical prolapse repairs with polypropylene mesh inlays.
本研究旨在调查在过去十年中,随着美国食品药品监督管理局(FDA)发出警告,全球对网片增强重建手术的态度发生变化,单中心科室针对盆腔器官脱垂(POP)的手术管理策略有何改变。
研究组由2010年1月至2020年12月因重度症状性POP(≥2 POP-Q分度)接受手术的4180例患者组成。根据所进行的POP阴道手术类型,将患者分为三组:第1组 - 阴道原生组织修复(VNTR) - (n = 1376);第2组 - 经阴道网片修复(TVM;前位、后位或两者皆有) - (n = 2494),以及第3组 - 经阴道子宫切除术(TVH) - (n = 310)。每种手术类型的临床疗效均根据美国国立卫生研究院盆底疾病网络标准进行评估。
自2017年FDA就这些手术的安全性发出警告后,VNTR手术数量显著增加。随访期间,各研究组的再次手术率无差异。然而,与TVM组和TVH组相比,VNTR组的尿急发生率显著更低(p < 0.05)。
在大多数症状性POP病例中,阴道原生组织修复是一种安全有效的初始治疗方法。基于再次手术率和功能结果,我们未发现聚丙烯网片嵌体增强手术性脱垂修复有任何益处的证据。