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Completed

NCT Number: NCT04481906

Vaginal Mesh Procedures for Female Cystocele

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of cystocele

Exclusion criteria

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

Treatment and study plan

Vaginal mesh for female cystocele

Procedure

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

Primary outcomes

  1. POP-Q Ba point

    Time frame: Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly

    POP-Q Ba > II POP-Q stage

Secondary outcomes

  1. Functional and ultrasound manifestations

    Time frame: Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly

    Urinary incontinence, overactive bladder symptoms, voiding dysfunction, bladder neck position on ultrasound

Sponsors and collaborators

Lead sponsor

Cathay General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2014
First posted
Jul 22, 2020
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.