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.
Study Type
OBSERVATIONAL
Enrollment
4,147
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Beijing, Beijing Municipality, China
RECRUITINGThe incidence rate of complications
Postoperative follow-up and record the occurrence of complications according to the International Urogynecological Association-International Continence Society（IUGA-ICS）Complication Classification Coding(Category-Time-Site coding system).
Time frame: 12 months postoperatively
The incidence rate of complications
Postoperative follow-up and record the occurrence of complications according to the International Urogynecological Association-International Continence Society（IUGA-ICS）Complication Classification Coding(Category-Time-Site coding system).
Time frame: 36 months postoperatively
Anatomical cure rate in treated compartment of pelvic reconstructive surgery with trans-vaginal mesh
The percentage of patients who reach the anatomical success criteria at each time point（6 weeks, 3 months and each year, up to 3-year postoperatively）.The anatomical success is defined by a composite outcome that includes absence of vaginal bulge symptoms, absence of vaginal descent beyond the hymen and the absence of retreatment.
Time frame: 6 weeks, 3 months and each year, up to 3-year postoperatively
Change from preoperative scores of POP-Q(Pelvic organ prolapse quantitation) at each follow-up
POP-Q is used for evaluation the severity(staging) of prolapse by pelvic examination preoperatively and postoperatively. The score is reported in cm. The changes from baseline scores at 6 weeks, 3 months, 1 year and up to 3 years postoperatively are respectively compared.
Time frame: Preoperatively; At 6weeks, 3 months, 1 year and assessed up to 3 year postoperatively
Patient global impression of improvement (PGI-I)
The Chinese-version validated questionnaire PGI-I is used for assessing patients' subjective satisfaction to the pelvic floor reconstructions surgery. The PGI-I score ranges from 0\~7.
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Time frame: At 6weeks, 3 months, 1 year and assessed up to 3 year postoperatively
Changes in Pelvic Floor Distress Inventory-20 (PFDI-20) scores
The Chinese-version validated questionnaire Pelvic Floor Distress Inventory-short Form 20 scores \[PFDI-20\] is to evaluate the impact on pelvic floor function.
Time frame: Preoperatively; At 1 year and 3 year postoperatively
Changes in Pelvic Floor Impact Questionnaire-7（PFIQ-7）scores
The Chinese-version validated questionnaire Pelvic Floor Impact Questionnaire-7 \[PFIQ-7\] is to evaluate the impact on quality of life.
Time frame: Preoperatively; At 1 year and 3 year postoperatively
Changes in sexual function and measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire（PISQ-12）scores
The Chinese-version validated questionnaire Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire scores （PISQ-12） is to evaluate the impact on sexual function.
Time frame: Preoperatively; At 1 year and 3 year postoperatively