Clinical trial NCT05938881: Long-term Success Rate of Transvaginal Mesh for the Treatment of Pelvic Organ Prolapse: The Extended RCT Study
Official title: Long-term Success Rate of Transvaginal Mesh for the Treatment of Pelvic Organ Prolapse: The Extended RCT Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pelvic Organ Prolapse
Keywords: pelvic organ prolapse
surgery plastic
pelvic floor
polypropylenes
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 336
Sex: FEMALE
Minimum age (years): 53
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women enrolled in previous RCT study are invited to this extended study.

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.

Detailed description: The previous study is a randomized trial designed to compare the composite success rate between patients with self-cut mesh procedure and those with mesh-kit procedure. The original RCT study includes a 1-year follow up from the time of surgery, which is too short to evaluate the long-term sequelae of the surgical procedures. The goal of this long-term follow-up study is to extend the follow-up of women in the previous RCT study up to 10 years from the time of surgery and to compare the success and complication rates of the two surgical treatment groups over this extended time period.

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.

Eligibility criteria: 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 outcomes:
measure: Composite success
timeFrame: up to 10 years after procedure
Secondary outcomes:
measure: anatomic outcomes
timeFrame: up to 10 years after operation
measure: Change From Baseline PFIQ-7 Score
timeFrame: up to 10 years after operation
measure: Change From Baseline PFDI-20 Score
timeFrame: up to 10 years after operation
measure: Change From Baseline PISQ-12 Score
timeFrame: up to 10 years after operation
measure: Symptomatic improvement using patient global impression of change (PGI-C)
timeFrame: up to 10 years after operation
measure: Complications
timeFrame: up to 10 years after operation
Other outcomes:
Locations:
city: Foshan
country: China
facility: Foshan Maternal and Child Health Care Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangdong Medical College
state: Guangdong
city: Changsha
country: China
facility: Changsha Maternal and Child Health Care Hospital
state: Hunan
city: Changsha
country: China
facility: The Secong Xiangya Hospital of Central South University
state: Hunan
city: Wuxi
country: China
facility: Wuxi Maternal and Child Health Care Hospital
state: Jiangsu
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Xi'an
country: China
facility: Shanxi Provincial People's Hosptial
state: Shanxi
city: Chengdu
country: China
facility: Sichuan University West China Second University Hospital
state: Sichuan
city: Ürümqi
country: China
facility: the First Affiliated Hosptial of Xinjiang Medical University
state: Xiangjiang
city: Ürümqi
country: China
facility: The People's Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References: