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

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).

Study Overview

• Status: Recruiting
• Conditions: Pelvic Organ Prolapse

Detailed Description

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 (Anticipated): 4147

Contacts and Locations

• Study Contact: Name: Lan Zhu, MD; Phone Number: +8613911714696; Email: zhu_julie@vip.sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
      • Contact: Shuo Liang, MD; Phone Number: +86 13718879529; Email: leahleung@foxmail.com
      • Contact: Lan Zhu, MD; Phone Number: +86 13911714696; Email: zhu_julie@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women who prefer to undertake pelvic reconstruction surgery with trans-vaginal mesh for 1) a newly diagnosed severe POP: at least stage III (ICS-classification according to POP-Q system) in one or more compartments; 2) The failure or recurrence after pelvic floor reconstruction with native-tissue(symptomatic II and above).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Transvaginal mesh; Patients who undergo pelvic reconstruction surgery using trans-vaginal mesh (commercial mesh kits or self-cut synthesized mesh).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: The First Affiliated Hospital of Nanchang University; Southwest Hospital, China; Qilu Hospital of Shandong University; Shengjing Hospital; Shanghai 10th People's Hospital; Beijing Chao Yang Hospital; Guizhou Provincial People's Hospital; The Third Xiangya Hospital of Central South University; Shenzhen People's Hospital; Shaanxi Provincial People's Hospital; Henan Provincial People's Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Wuhan Union Hospital, China; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; People's Hospital of Xinjiang Uygur Autonomous Region; Renmin Hospital of Wuhan University; Obstetrics & Gynecology Hospital of Fudan University; Shanghai First Maternity and Infant Hospital; The Second Affiliated Hospital of Harbin Medical University; Second Xiangya Hospital of Central South University; First Affiliated Hospital of Xinjiang Medical University; Second Hospital of Jilin University; Fuzhou General Hospital; West China Second University Hospital; Nanjing Maternity and Child Health Care Hospital; Shanghai Jiao Tong University Affiliated Sixth People's Hospital; The Second Hospital of Anhui Medical University; Yantai Yuhuangding Hospital; Mianyang Central Hospital; Wuhan Central Hospital; Fourth Medical Center of PLA General Hospital; Yangpu District Central Hospital Affiliated to Tongji University; Jiangxi Maternal and Child Health Hospital; Chongqing Medical Center for Women and Children; Dalian Maternity and Child Care Hospital; Affiliated Wuhu Clinical College of Nantong University; Changsha Maternal And Child Health Care Hospital; Shanxi Coal Center Hospital; Affiliated Renhe Hospital of China Three Gorges University, China; The First Affiliated Hospital of the Medical College, Shihezi University，China

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 10, 2019
• Primary Completion (ANTICIPATED): December 1, 2025
• Study Completion (ANTICIPATED): June 1, 2026

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (ACTUAL): July 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 21, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: complications; trans-vaginal mesh; pelvic reconstruction surgery; the CTS(category-time-site) coding system
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: JS-1979

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No