A Multi-center Registry Study: The Follow-up the Complications for Trans-vaginal Mesh Surgery

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Multi-center Registry Study: The Complications After Women Having Pelvic Reconstruction Surgery With Trans-vaginal Mesh

Conditions
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Pelvic Organ Prolapse

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1） Patients who undergo the pelvic reconstruction surgery with trans-vaginal mesh; 2) Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation; 3）Willing to participate in 36 months of longitudinal follow-up and able to provide written informed consent. Willing to provide an email address and complete questionnaires on we-chat, either in clinic or elsewhere when they have access to the internet. Exclusion Criteria: 1) Currently pregnant at enrollment; 2) Physically or mentally unable to participate in up to 36 months of follow-up; 3) Desires other surgical management of POP other than trans-vaginal mesh.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transvaginal mesh<br>Patients who undergo pelvic reconstruction surgery using trans-vaginal mesh (commercial mesh kits or self-cut synthesized mesh). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 36 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | Preoperatively; At 1 year and 3 year postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trans-vaginal mesh, pelvic reconstruction surgery, complications, the CTS(category-time-site) coding system