Self-cut titanium-coated polypropylene mesh versus pre-cut mesh-kit for transvaginal treatment of severe pelvic organ prolapse: study protocol for a multicenter non-inferiority trial.

ABSTRACT:

Background

Pelvic organ prolapse (POP) is a common health problem and has significant negative effects on a woman's quality of life. The transvaginal mesh procedure is a durable reconstructive surgery, but the mesh kits are expensive for underdeveloped countries. Our previous case-series study showed that the use of self-cut mesh had a good success rate (91.8% at 1-year follow-up) and low complication rate. This trial is designed to compare a self-cut titanium-coated polypropylene mesh procedure with a mesh kit for the treatment of symptomatic stage III-IV anterior or apical prolapse in terms of efficacy, safety and cost-effectiveness.

Methods

The trial is a randomized controlled multicenter non-inferiority trial. The primary outcome measure is the composite success rate at

SUBMITTER: Chen J 

PROVIDER: S-EPMC7045611 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature