Long-term Success Rate of Transvaginal Mesh for the Treatment of Pelvic Organ Prolapse: The Extended RCT Study
1 other identifier
observational
336
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2023
CompletedStudy Start
First participant enrolled
June 29, 2023
CompletedFirst Posted
Study publicly available on registry
July 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 12, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 12, 2033
July 11, 2023
July 1, 2023
9.5 years
June 28, 2023
July 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite success
To determine the long-term (up to 10 years) composite success rate of both procedure (defined as leading edge above the hymen (i.e Ba, C, Bp\<0 cm) AND deny vaginal bulging symptoms indicated by a negative response question 3 of the pelvic floor distress inventory- 20 (PFDI-20): "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area? AND no re-operation or pessary treatment for POP), and whether composite success rate differs between women who had self-cut mesh procedure vs. those who had mesh-kit procedure; This outcome measure is cumulative across the original RCT trial and continued through the extended trial follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)
up to 10 years after procedure
Secondary Outcomes (6)
anatomic outcomes
up to 10 years after operation
Change From Baseline PFIQ-7 Score
up to 10 years after operation
Change From Baseline PFDI-20 Score
up to 10 years after operation
Change From Baseline PISQ-12 Score
up to 10 years after operation
Symptomatic improvement using patient global impression of change (PGI-C)
up to 10 years after operation
- +1 more secondary outcomes
Study Arms (2)
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.
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.
Interventions
transvaginal mesh procedure using self-cut mesh
Eligibility Criteria
All women enrolled in previous RCT study are invited to this extended study.
You may qualify if:
- Women enrolled in previous RCT study
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 28, 2023
First Posted
July 11, 2023
Study Start
June 29, 2023
Primary Completion (Estimated)
January 12, 2033
Study Completion (Estimated)
March 12, 2033
Last Updated
July 11, 2023
Record last verified: 2023-07