Clinical Outcomes and Urodynamic Effects After Vaginal Tailored Mesh Surgery for Pelvic Organ Prolapse

January 27, 2016 updated by: National Taiwan University Hospital
To evaluate the clinical outcome and urodynamic effect of two novel vaginal tailored mesh surgeries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We will review the medical records (including medical data, urodynamic data, pad weight data, etc) of women who underwent either anterior or posterior novel vaginal tailored mesh surgeries at National Taiwan University Hospital between November 2011 and November 2013.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 4

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, 100
        • Department of Obstetrics & Gynecology, National Taiwan University 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 to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All women with pelvic organ prolapse who underwent either anterior or/and posterior vaginal tailored mesh surgeries in National Taiwan University Hospital between November 2011 and November 2013

Exclusion Criteria: nil

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

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Anterior compartment prolapse
Woman with cystocele who underwent anterior vaginal tailored mesh surgery
Procedure: Anterior vaginal tailored mesh surgery
Anterior vaginal tailored mesh surgery for repair of cystocele with or without stress urinary incontinence
EXPERIMENTAL: Posterior compartment prolapse
Woman with rectocele, enterocele, uterine prolapse, vaginal stump prolpase who underwent posterior vaginal tailored mesh surgery
Procedure: Posterior vaginal tailored mesh surgery
Posterior vaginal tailored mesh surgery for repair of enterocele, rectocele, vaginal vault prolapse or uterine prolapse
EXPERIMENTAL: anterior and posterior prolapse
Woman with cystocele and rectocele/uterine prolapse/vaginal vault prolapse/enterocele who underwent anterior and posterior vaginal tailored mesh surgery
Procedure: Anterior vaginal tailored mesh surgery
Anterior vaginal tailored mesh surgery for repair of cystocele with or without stress urinary incontinence
Procedure: Posterior vaginal tailored mesh surgery
Posterior vaginal tailored mesh surgery for repair of enterocele, rectocele, vaginal vault prolapse or uterine prolapse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of pelvic organ prolapse
Time Frame: 1 year
Recurrence rate of cystocele, rectocele, uterine prolapse, or vaginal vault prolapse within 1 year after surgery
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of pad weight
Time Frame: 3 months
The change of pad weight between baseline and 3 months after surgery for pelvic organ prolapse
3 months
The change of maximum urethral closure pressure
Time Frame: 3 months
The difference of maximum urethral closure pressure between baseline and 3 months after surgery
3 months
Vaginal mesh erosion
Time Frame: 1 year
Vaginal mesh erosion rate within 1 year after surgery
1 year

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2014

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

November 1, 2015

Study Registration Dates

First Submitted

June 9, 2014

First Submitted That Met QC Criteria

June 27, 2014

First Posted (ESTIMATE)

July 1, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 29, 2016

Last Update Submitted That Met QC Criteria

January 27, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201404024RINC

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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