Vaginal Mesh Procedures for Female Cystocele

July 19, 2020 updated by: Cathay General Hospital

Long-term Follow-up of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10630
        • Cathay General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women 20 years or older with cystocele

Description

Inclusion Criteria:

  • Clinical diagnosis of cystocele

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women 20 years and older with cystocele
Procedure: Vaginal mesh for female cystocele
Vaginal mesh procedures (e.g. Perigee) were susgested for women with POP-Q stage III or more cystocele

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cathay General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 25, 2011

Primary Completion (Actual)

June 16, 2012

Study Completion (Actual)

October 5, 2014

Study Registration Dates

First Submitted

July 16, 2018

First Submitted That Met QC Criteria

July 19, 2020

First Posted (Actual)

July 22, 2020

Study Record Updates

Last Update Posted (Actual)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 19, 2020

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGH-P100072

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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