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

Recruitingn/aAges 53 Years - 75 YearsFemalePeking Union Medical College Hospital
NCT05938881 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Women enrolled in previous RCT study Exclusion Criteria: * Inability to provide informed consent. Informed consent will be obtained prior to each telephone interview and each in-person visit. * Subjects who appear to have cognitive deficits during the in-person visit or site telephone interview will be withdrawn from the study by the study coordinator.
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What it tests

  • self-cut mesh procedure
  • mesh-kit procedure
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Where

11 sites
Foshan Maternal and Child Health Care Hospital
Foshan, China
The First Affiliated Hospital of Guangdong Medical College
Guangzhou, China
Changsha Maternal and Child Health Care Hospital
Changsha, China
The Secong Xiangya Hospital of Central South University
Changsha, China
Wuxi Maternal and Child Health Care Hospital
Wuxi, China
Qilu Hospital of Shandong University
Jinan, China
Shanxi Provincial People's Hosptial
Xi’an, China
Sichuan University West China Second University Hospital
Chengdu, China

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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