Long-term evaluation of transvaginal mesh for pelvic organ prolapse

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

This study follows women who had surgery for pelvic organ prolapse to see how well the treatments work and if there are any long-term problems up to 10 years later.

Quick facts

• Study type: Observational
• Enrollment: 336 (estimated)
• Ages: 53 Years to 75 Years
• Sex: Female
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 11 sites (Foshan, Guangdong and 10 other locations)
• Trial ID: NCT05938881 on ClinicalTrials.gov

What this trial studies

This observational study aims to follow women who previously participated in a randomized controlled trial comparing two surgical techniques for pelvic organ prolapse: the self-cut mesh procedure and the mesh-kit procedure. The focus is on assessing the long-term success and complication rates of these treatments over a period of up to 10 years post-surgery. Participants will be encouraged to engage in annual examinations and telephone surveys to gather comprehensive data on their outcomes. No new interventions will be administered, as this study is solely focused on long-term follow-up of existing participants.

Who should consider this trial

Good fit: Ideal candidates for this study are women who have previously participated in the original randomized controlled trial.

Not a fit: Patients who did not participate in the previous RCT or those unable to provide informed consent will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of transvaginal mesh procedures for treating pelvic organ prolapse.

How similar studies have performed: Other studies have explored similar surgical techniques, but this long-term follow-up approach is relatively novel in evaluating the outcomes of transvaginal mesh procedures.

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* Subjects who appear to have cognitive deficits during the in-person visit or site telephone interview will be withdrawn from the study by the study coordinator.

Where this trial is running

Foshan, Guangdong and 10 other locations

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

Study contacts

• Study coordinator: Lan Zhu

Conditions Pelvic Organ Prolapse; pelvic organ prolapse; surgery plastic; pelvic floor; polypropylenes