NCT03283124

Comparing Transvaginal Self-tailored Titanium-coated Polypropylene Mesh Procedure With Mesh-kit Procedure.

A Multicenter Randomized Controlled Non-inferiority Trial Comparing Transvaginal Self-tailored Titanium-coated Polypropylene Mesh Procedure With Mesh-kit Procedure.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Pelvic organ prolapse(POP) is a common health problem and has significant negative effects on woman's quality of life. Transvaginal mesh procedure is a durable reconstructive surgery, but the mesh kits are expensive for underdeveloped countries. Our preliminary trial showed that the use of self-tailored mesh had good success rate (91.8% at 1-year follow-up) and low complication rate. The 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 .

Detailed description

The trial is a randomized controlled multi-center non-inferiority trial. The primary outcome measure is success rate at 1-year follow-up. The second outcomes are subjective improvement of quality of life, complications and costs. Analysis will be performed according to the intention to treat principle. Based on comparable success rate of 90% and 10% as the margin(beta 0.2 and one sided alpha 0.025), about 312 patients in total from 11 centers will be recruited per group including 10% drop-out. The aims of the research are to demonstrate whether self-tailored mesh is non-inferior to the mesh-kit. The finding of this research might influence the treatment selection for POP in China.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
PROCEDURE	pelvic floor reconstructive surgery	transvaginal mesh implantation for pelvic organ prolapse

Timeline

• Start date: 2018-01-12
• Primary completion: 2020-01-12
• Completion: 2022-01-12
• First posted: 2017-09-14
• Last updated: 2019-03-05

Locations

11 sites across 1 country: China