Efficacy/Safety of Urogynecology Synthetic Mesh Surgery

Status Recruiting

Clinical Trial Summary

This is a retrospective cohort study, aiming at analyzing the efficacy and safety of mesh surgery in pelvic organ prolapse. The synthetic mesh for pelvic organ prolapse include transvaginal mesh or laparotomy, laparoscope, or robotic-assisted laparoscopic sacrocolpopexy with mesh augmentation. The investigators would like to evaluate the efficacy and safety, such as recurrence rates and complication rates for women who underwent urogynecology mesh surgery.

Clinical Trial Description

Gynecologic mesh, including transvaginal mesh and mesh used in abdominal or laparoscopic sacrocolpopexy, has been used for pelvic organ prolapse since its debut in the US in 2005. It provides higher success and satisfaction rate than traditional colporrhaphy, but mesh-related complications, such as pain, mesh exposure and bleeding, have been reported. U.S. Food and Drug Administration issued a Safety Update in 2011 to inform the public that serious complications associated with synthetic mesh for the transvaginal repair of POP were common. Taiwan FDA and associated committees decided that the use of gynecologic mesh should be regulated. Thorough study and evaluation are needed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05682989
Study type	Observational
Source	Mackay Medical College
Contact	Hui-Hsuan Lau, M.D.
Phone	+886-975-835928
Email	huihsuan1220@gmail.com
Status	Recruiting
Phase
Start date	August 1, 2022
Completion date	December 31, 2027

View Details

See also
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