Pelvic Organ Prolapse Clinical Trial
Official title:
A Multi-center Registry Study: The Complications After Women Having Pelvic Reconstruction Surgery With Trans-vaginal Mesh
This is a multi-center, prospective, observational, hospital-based registry of pelvic organ prolapse(POP) patients who having trans-vaginal mesh implantation with 12 month and 36 month follow-up.To investigate the incidence of postoperative complications according to the International Urogynecological Association/International Continence Society (IUGA/ICS) complication classification system(the Category- Time-Site(CTS) coding).
Patients who undergo pelvic floor reconstructive surgery with trans-vaginal mesh for the cure
of pelvic organ prolapse (POP) between June 2019 and December 2022 from 41 centers across the
country are going to be prospectively collected. The study is designed to report the clinical
data，outcomes and complications of transvaginal mesh surgery in China. The information
gathered will identify the incidence rate of complications, especially mesh exposure/erosion,
in Chinese women and whether published, professional guidelines on POP surgical treatment as
well as mesh complications management are being applied appropriately. Findings from this
registry may help in knowing the current status of transvaginal mesh use in China as well as
identify issues that may affect the surgical outcome and complications occurrence. Based on
the registry study, clinical practice on the management of transvaginal mesh implantation
including selection patients, pre- and post-operative evaluation and complications surgical
database will be established.
The follow-up process starts after patients have completed the operation; thus, our study
does not affect patients' choice of surgical method.
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