Long-term evaluation of transvaginal mesh for pelvic organ prolapse

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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* Subjects who appear to have cognitive deficits during the in-person visit or site telephone interview will be withdrawn from the study by the study coordinator.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

• 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

Study contacts

• Study coordinator: Lan Zhu
• Email: zhu_julie@sina.com
• Phone: 86-10-69155749

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Vaginal Vault Support at Hysterectomy

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• Centered Surgery: Preoperative Counseling to Improve Patient Satisfaction

  This study will test whether virtual group counseling sessions (shared medical appointments) help adults having pelvic organ prolapse surgery feel more satisfied and better prepared compared with standard individual phone calls.

  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT07471464

• Pelvic floor muscle training with and without hypopressive exercises for women with pelvic organ prolapse

  This will test whether adding hypopressive exercises to pelvic floor muscle training helps women aged 45–65 with stage I–II pelvic organ prolapse improve pelvic floor strength, reduce pain during sex, and feel better overall.

  Recruiting Riphah International University · Lahore, Punjab Province · NCT07440875

• Wrist activity tracking to guide early recovery after pelvic organ prolapse surgery

  This study will try giving women having pelvic organ prolapse surgery either usual postoperative advice or a guided early-exercise plan while tracking activity with a wrist accelerometer to see which group reaches "mostly recovered" sooner.

  Recruiting at 6 sites NICHD Pelvic Floor Disorders Network · San Diego, California and 6 other locations · NCT07218016

• Mesh-free sacrocolpopexy using the VNOTES (transvaginal endoscopic) approach for pelvic organ prolapse

  This trial will try mesh-free sacrocolpopexy using the VNOTES transvaginal endoscopic technique in women with stage II or higher pelvic organ prolapse to see if it improves pelvic support, symptoms, and sexual function over six months.

  Recruiting at 2 sites Gaziosmanpasa Research and Education Hospital · Istanbul and 1 other locations · NCT07114029

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.