NCT05938881

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 336 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 53 Years – 75 Years
• Healthy volunteers: —

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.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
PROCEDURE	self-cut mesh procedure	transvaginal mesh procedure using self-cut mesh
PROCEDURE	mesh-kit procedure	transvaginal mesh procedure using mesh-kit

Timeline

• Start date: 2023-06-29
• Primary completion: 2033-01-12
• Completion: 2033-03-12
• First posted: 2023-07-11
• Last updated: 2023-07-11

Locations

11 sites across 1 country: China