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

NCT05938881 · tracked via the Priya Life Science China tracker

Sponsor

Peking Union Medical College Hospital

Phase

Observational

Started

2023-06-29

Last updated

2023-07-11

Condition(s) studied

Pelvic Organ Prolapse

Investigational drug(s) / intervention(s)

self-cut mesh proceduremesh-kit procedure

self-cut mesh procedure: transvaginal mesh procedure using self-cut mesh

mesh-kit procedure: transvaginal mesh procedure using mesh-kit

Study 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.

Eligibility

Sex

FEMALE

Min age

53 Years

Max age

75 Years

Healthy volunteers

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 * Subjects who appear to have cognitive deficits during the in-person visit or site telephone interview will be withdrawn from the study by the study coordinator.

Primary outcome measure(s)

Composite success — up to 10 years after procedure
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.)

Trial sites (11)

Facility	City	Region	Status
Foshan Maternal and Child Health Care Hospital	Foshan	Guangdong	Recruiting
The First Affiliated Hospital of Guangdong Medical College	Guangzhou	Guangdong	Recruiting
Changsha Maternal and Child Health Care Hospital	Changsha	Hunan	Recruiting
The Secong Xiangya Hospital of Central South University	Changsha	Hunan	Recruiting
Wuxi Maternal and Child Health Care Hospital	Wuxi	Jiangsu	Recruiting
Qilu Hospital of Shandong University	Jinan	Shandong	Recruiting
Shanxi Provincial People's Hosptial	Xi’an	Shanxi	Recruiting
Sichuan University West China Second University Hospital	Chengdu	Sichuan	Recruiting
the First Affiliated Hosptial of Xinjiang Medical University	Ürümqi	Xiangjiang	Recruiting
The People's Hospital of Xinjiang Uygur Autonomous Region	Ürümqi	Xinjiang	Recruiting
Peking Union Medical College Hospital	Beijing	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05938881 on ClinicalTrials.gov ↗ ← All trials in China