NCT04025047

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,147

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress99%
Apr 2019Jun 2026

Study Start

First participant enrolled

April 10, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

6.6 years

First QC Date

July 17, 2019

Last Update Submit

July 21, 2019

Conditions

Pelvic Organ Prolapse

Keywords

trans-vaginal meshpelvic reconstruction surgerycomplicationsthe CTS(category-time-site) coding system

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Anatomical cure rate in treated compartment of pelvic reconstructive surgery with trans-vaginal mesh

    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

    Preoperatively; At 6weeks, 3 months, 1 year and assessed up to 3 year postoperatively

  • Patient global impression of improvement (PGI-I)

    At 6weeks, 3 months, 1 year and assessed up to 3 year postoperatively

  • Changes in Pelvic Floor Distress Inventory-20 (PFDI-20) scores

    Preoperatively; At 1 year and 3 year postoperatively

  • Changes in Pelvic Floor Impact Questionnaire-7（PFIQ-7）scores

    Preoperatively; At 1 year and 3 year postoperatively

  • +1 more secondary outcomes

Study Arms (1)

Transvaginal mesh

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • ） 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.

You may not qualify if:

  • \) Currently pregnant at enrollment;
  • \) Physically or mentally unable to participate in up to 36 months of follow-up;
  • \) Desires other surgical management of POP other than trans-vaginal mesh.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Lan Zhu, MD

    Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuo Liang, MD

CONTACT

+8613718879529leahleung@foxmail.com

Lan Zhu, MD

CONTACT

+8613911714696zhu_julie@vip.sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, the Chief of General Gynecology Center, the Department of Obstetrics & Gynecology

Study Record Dates

First Submitted

July 17, 2019

First Posted

July 18, 2019

Study Start

April 10, 2019

Primary Completion

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

July 23, 2019

Record last verified: 2019-07

Locations

CN(1)