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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04025047
• Other study ID #: JS-1979
• Status: Recruiting
• Start date: April 10, 2019
• Est. completion date: June 2026

Study information

• Verified date: July 2019
• Source: Peking Union Medical College Hospital
• Contact: Shuo Liang, MD
• Phone: +8613718879529
• Email: leahleung[@]foxmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4147
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences	Beijing	Beijing

Sponsors (41)

Lead Sponsor

Collaborator

Peking Union Medical College Hospital

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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