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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура self-cut mesh procedure
  transvaginal mesh procedure using self-cut mesh
• Процедура mesh-kit procedure
  transvaginal mesh procedure using mesh-kit

Первичные конечные точки

• Composite success [Срок оценки: up to 10 years after procedure]

Вторичные конечные точки (6)

• anatomic outcomes [Срок оценки: up to 10 years after operation]
• Change From Baseline PFIQ-7 Score [Срок оценки: up to 10 years after operation]
• Change From Baseline PFDI-20 Score [Срок оценки: up to 10 years after operation]
• Change From Baseline PISQ-12 Score [Срок оценки: up to 10 years after operation]
• Symptomatic improvement using patient global impression of change (PGI-C) [Срок оценки: up to 10 years after operation]
• Complications [Срок оценки: up to 10 years after operation]

Критерии участия

Критерии включения

• Women enrolled in previous RCT study

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 11 центров

• Foshan Maternal and Child Health Care Hospital — Foshan
• The First Affiliated Hospital of Guangdong Medical College — Гуанчжоу
• Changsha Maternal and Child Health Care Hospital — Чанша
• The Secong Xiangya Hospital of Central South University — Чанша
• Wuxi Maternal and Child Health Care Hospital — Wuxi
• Qilu Hospital of Shandong University — Цзинань
• Shanxi Provincial People's Hosptial — Xi’an
• Sichuan University West China Second University Hospital — Чэнду
• … и ещё 3 центра

Идентификаторы

NCT: NCT05938881 · extended TVM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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