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Long-term Success Rate of Transvaginal Mesh for the Treatment of Pelvic Organ Prolapse: The Extended RCT Study
Sponsor: Peking Union Medical College Hospital
Summary
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.
Key Details
Gender
FEMALE
Age Range
53 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
336
Start Date
2023-06-29
Completion Date
2033-03-12
Last Updated
2023-07-11
Healthy Volunteers
Not specified
Conditions
Interventions
self-cut mesh procedure
transvaginal mesh procedure using self-cut mesh
mesh-kit procedure
transvaginal mesh procedure using mesh-kit
Locations (11)
Foshan Maternal and Child Health Care Hospital
Foshan, Guangdong, China
The First Affiliated Hospital of Guangdong Medical College
Guangzhou, Guangdong, China
Changsha Maternal and Child Health Care Hospital
Changsha, Hunan, China
The Secong Xiangya Hospital of Central South University
Changsha, Hunan, China
Wuxi Maternal and Child Health Care Hospital
Wuxi, Jiangsu, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shanxi Provincial People's Hosptial
Xi’an, Shanxi, China
Sichuan University West China Second University Hospital
Chengdu, Sichuan, China
the First Affiliated Hosptial of Xinjiang Medical University
Ürümqi, Xiangjiang, China
The People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China
Peking Union Medical College Hospital
Beijing, China