Long-term Success Rate of Transvaginal Mesh for the Treatment of Pelvic Organ Prolapse: The Extended RCT Study
NCT ID: NCT05938881
Last Updated: 2023-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
336 participants
OBSERVATIONAL
2023-06-29
2033-03-12
Brief Summary
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Detailed Description
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The primary aim is to determine whether treatment success in women who undergo the above strategies differ at time points through 10 years. A supplemental study investigates the long-term success rate and complications of transvaginal mesh procedure in women in both of the study arms.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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self-cut mesh procedure
This procedure is transvaginal mesh implantation surgery for POP patients. Self-cut mesh procedure is an economic pelvic reconstructive surgical operation with use of specially designed puncture needles and self-cut mesh, which mainly provide anterior and apical compartments support, with posterior compartment reinforced by bridge technique repair. The mesh pieces used in this surgery was cut from a single piece of mesh material(TiLOOP 10\*15cm) which is much cheaper and readily available. Patients could have transvaginal hysterectomy concomitantly.
self-cut mesh procedure
transvaginal mesh procedure using self-cut mesh
mesh-kit procedure
This procedure is transvaginal mesh implantation surgery for POP patients.Mesh-kit procedure is refered to pelvic floor reconstructive surgery with titanium-coated meshes kit(TiLOOP TOTAL6).Patients could have transvaginal hysterectomy concomitantly.
mesh-kit procedure
transvaginal mesh procedure using mesh-kit
Interventions
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self-cut mesh procedure
transvaginal mesh procedure using self-cut mesh
mesh-kit procedure
transvaginal mesh procedure using mesh-kit
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subjects who appear to have cognitive deficits during the in-person visit or site telephone interview will be withdrawn from the study by the study coordinator.
53 Years
75 Years
FEMALE
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Lan Zhu
Professor
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Yuling Wang
Role: primary
Xiaowei Zhang
Role: primary
Binan Wang
Role: primary
Guangshi Tao
Role: primary
Jian Gong
Role: primary
Peishu Liu
Role: primary
Xiangyang Jiang
Role: primary
Ping Wang
Role: primary
Gulina Ababaikeli
Role: primary
Hatiguli Nisier
Role: primary
Juan Chen
Role: primary
Other Identifiers
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extended TVM
Identifier Type: -
Identifier Source: org_study_id
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