Actively Recruiting

Age: 53Years - 75Years
FEMALE
NCT05938881

Long-term Success Rate of Transvaginal Mesh for the Treatment of Pelvic Organ Prolapse: The Extended RCT Study

Led by Peking Union Medical College Hospital · Updated on 2023-07-11

336

Participants Needed

11

Research Sites

506 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The original RCT trial is designed to compare self-tailored titanium-coated polypropylene mesh procedure with mesh-kit in the treatment of POP stage III-IV in terms of efficacy, safety and cost-effective at 1-year follow-up. This study will follow women in the original RCT study for up to 10 years from the time of the surgery to compare success and complication rates in the two groups. Recruitment into this study is open only to women that already participated in previous RCT, no new treatment interventions will be given. Recruitment into the previous RCT is closed. Women will be strongly encouraged to participate in annual examinations and annual telephone surveys but may participate in only one of these study parts if needed.

CONDITIONS

Official Title

Long-term Success Rate of Transvaginal Mesh for the Treatment of Pelvic Organ Prolapse: The Extended RCT Study

Who Can Participate

Age: 53Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women enrolled in previous RCT study
Not Eligible

You will not qualify if you...

  • Inability to provide informed consent
  • Withdrawal if cognitive deficits are detected during visits or telephone interviews

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 11 locations

1

Foshan Maternal and Child Health Care Hospital

Foshan, Guangdong, China

Actively Recruiting

2

The First Affiliated Hospital of Guangdong Medical College

Guangzhou, Guangdong, China

Actively Recruiting

3

Changsha Maternal and Child Health Care Hospital

Changsha, Hunan, China

Actively Recruiting

4

The Secong Xiangya Hospital of Central South University

Changsha, Hunan, China

Actively Recruiting

5

Wuxi Maternal and Child Health Care Hospital

Wuxi, Jiangsu, China

Actively Recruiting

6

Qilu Hospital of Shandong University

Jinan, Shandong, China

Actively Recruiting

7

Shanxi Provincial People's Hosptial

Xi’an, Shanxi, China

Actively Recruiting

8

Sichuan University West China Second University Hospital

Chengdu, Sichuan, China

Actively Recruiting

9

the First Affiliated Hosptial of Xinjiang Medical University

Ürümqi, Xiangjiang, China

Actively Recruiting

10

The People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, China

Actively Recruiting

11

Peking Union Medical College Hospital

Beijing, China

Actively Recruiting

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Research Team

L

Lan Zhu

CONTACT

J

Juan Chen

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Long-term Success Rate of Transvaginal Mesh for the Treatment of Pelvic Organ Prolapse: The Extended RCT Study | DecenTrialz