NCT04481906

Vaginal Mesh Procedures for Female Cystocele

Long-term Follow-up of Vaginal Mesh Procedures for Female Cystocele

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 160 (actual)
• Sponsor: Cathay General Hospital · Academic / Other
• Sex: Female
• Age: 240 Months
• Healthy volunteers: Accepted

Summary

This study aimed to evaluate primarily the functional outcomes and secondly the morphological outcomes for women who had received standard managements for cystocele at mediate-term follow-up.

Detailed description

Pelvic organ prolapsed (POP) is an important health issue for women all over the world, with cystocele being the commonest type of POP. The side effects related to cystocele include voiding dysfunction, urinary retention, urinary tract infection, hydroureter, or hydronephrosis. The management for cystocele can be classified as non-surgical and surgical methods. Non-surgical methods comprise pelvic floor muscle exercise and vaginal pessaries, while surgical methods can be divided as conventional operations and operations applying mesh augmentation. Conventional surgeries for cystocele such as anterior colporrhapy have high surgical failure rates and complications including vaginal shortening or vaginal stenosis. Operations applying mesh augmentation are becoming the mainstream in the surgeries for cystocle. The Perigee System (American Medical Systems, Minnetonka, MN, USA), which has been approved by American FDA and Taiwan DOH in treating female cystocele, have promising short-term surgical outcomes. However, long-term reports incorporating both functional and morphological outcomes are lacking in the literatures. This study aimed to evaluate primarily the functional outcomes and secondly the morphological outcomes for women who had received standard managements for cystocele at mediate-term follow-up.

Conditions

• Cystocele

Interventions

Type	Name	Description
PROCEDURE	Vaginal mesh for female cystocele	Vaginal mesh procedures (e.g. Perigee) were susgested for women with POP-Q stage III or more cystocele

Timeline

• Start date: 2011-10-25
• Primary completion: 2012-06-16
• Completion: 2014-10-05
• First posted: 2020-07-22
• Last updated: 2020-07-22

Locations

1 site across 1 country: Taiwan