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Vaginal Mesh Procedures for Female Cystocele

C

Cathay General Hospital

Status

Completed

Conditions

Cystocele

Treatments

Procedure: Vaginal mesh for female cystocele

Study type

Observational

Funder types

Other

Identifiers

NCT04481906
CGH-P100072

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 patients

Sex

Female

Ages

240+ months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Clinical diagnosis of cystocele

Exclusion criteria

  • Pregnancy or possibility of future pregnancy
  • Urinary tract infection
  • Diabetes
  • Neurological diseases
  • Cardiovascular diseases

Trial design

160 participants in 1 patient group

Women 20 years and older with cystocele
Description:
Women 20 years and older with cystocele
Treatment:
Procedure: Vaginal mesh for female cystocele

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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