The Immune Reactivity of Biofilms in Vaginal Mesh Erosion.

November 26, 2007 updated by: Chang Gung Memorial Hospital

Does the Immune Reactivity of Bacteria Cause Vaginal Mesh (Polypropylene) Erosion? - A Ultrastructural, Microbiological and Immunohistochemical Analysis.

Aging, birth trauma and extensive pelvic surgery are the causes known to cause advanced pelvic organ prolaspe, fecal as well as urinary incontinence. Surgical treatment is the last resort to manage the above-mentioned clinical manifestations of pelvic floor disorders except the subject is too frail to receive operation.

In order to improve the outcome of reconstructive pelvic surgery, reinforcement with synthetic mesh or biological material is the modern trend in pelvic repair. Unfortunately no prosthesis including synthetic or biological is ideal because vaginal erosion with mesh extrusion which is the subject of this protocol and other complications were reported continuously. As per the literature, the rate for mesh vaginal extrusion ranged between 2.4 and 17% when polypropylene which is the most popular synthetic material used for the mid-urethral sling or pelvic reconstructive surgery to date. The causes of this complication are still controversial which include rejection, poor quality of tissue, surgical artifact, material of mesh and etc.

A prospective controlled study for the investigation of the cause for mesh vaginal erosion was conducted and the results revealed evidences of immune reactivity after mesh implantation, albeit the evidence was not solid (Am J Obstet Gynecol 2004; 191(6): 1868-1874 ). As per the pilot study initially done by us to determine the biofilm-related-infection, we have found bacterial biofilm could adhere to surfaces and interfaces, i.e. bacteria located in the cells just beneath the contacting surfaces in the electron microscopic (EM) analysis. In addition, soon after bacteria infection, proteins in biofilm undergo conformational changes, making them immunogenic and triggers a typical inflammatory response leading to activation of the complement system. Thus, we plan to use CD (clusters of differentiation) antigens - 4, 8, 20, 25, 40, 68 and quantitative analysis of FoxP3 to determine the function of regulatory T cells in the immune response. In addition, bacterial culture and EM analysis of the excised mesh with surrounding vagina tissue will be performed for further analysis of biofilms.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

82

Phase

  • Not Applicable

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
    • Taoyuan
      • Gueishan, Taoyuan, Taiwan, 333
        • Chang Gung Memorial 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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Study arm: Subjects present with mesh erosion in vaginal after placement of polypropylene mesh for either urinary stress incontinence or pelvic organ prolapse.
  • Control arm: Subjects present with symptomatic vaginal prolapse but without mesh erosion after placement of polypropylene mesh for either urinary stress incontinence or pelvic organ prolapse.

Exclusion Criteria:

  • Study arm: The eligible subjects with fasting sugar level ≥ 180mg/dL, post prandial sugar level ≥ 230mg/dL.
  • Control arm: Polypropylene mesh placement less than 6 months.

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: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
Procedure: excision of the protruding mesh and its surrounding vaginal tissue
A piece of vaginal tissue 12mm*5mm*3mm in sized (for control group) and another piece of vaginal tissue combined with protruding mesh of the same size (for study group) will be obtained respectively for each of the two arms during intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine whether bacterial infection with biofilm formation exists in the vaginal tissue with mesh extrusion using bacterial culture and electron microscopic analysis.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
With the use of immunohistochemical (IHC) analysis of CD 4, 8, 20, 25, 40, 68 and quantitative analysis of Fox P3 (using RT-POR), to determine the function of regulatory T cells in the immune reactivity of biofilms.
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial Hospital

Collaborators

National Science Council, Taiwan

Investigators

  • Principal Investigator: Alex Wang, MD, Division of Female Pelvic Medicine and Reconstructive Surgery, Department of OB/GYN, Chang Gung Memorial Hospital
  • Study Chair: Cheng-Hsun Chiu, MD. PhD, Department of Pediatrics, Chang Gung Memorial Hospital
  • Study Director: Yu-Shien Ko, MD, PhD, First Cardiovascular Division, Chang Gung Memorial Hospital
  • Study Director: Cheng-Tao Lin, MD, Division of Gynecological Oncology, Department of OB/GYN, Chang Gung Memorial Hospital
  • Study Director: Ren-Chin Wu, MD, Department of Surgical Pathology, Chang Gung Memorial Hospital
  • Study Director: Tsia-Shu Lo, MD, Division of Female Pelvic Medicine and Reconstructive Surgery, Department of OB/GYN, Chang Gung Memorial Hospital
  • Study Director: Min-Chi Chen, PhD, Biostatistics Center and Department of Public Health, Chang Gung University
  • Study Director: Yi-Haou Lin, MD, Division of Female Pelvic Medicine and Reconstructive Surgery, Department of OB/GYN, Chang Gung Memorial 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

August 1, 2007

Study Completion (ANTICIPATED)

July 1, 2009

Study Registration Dates

First Submitted

November 25, 2007

First Submitted That Met QC Criteria

November 26, 2007

First Posted (ESTIMATE)

November 27, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

November 27, 2007

Last Update Submitted That Met QC Criteria

November 26, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRPD160851
  • NSC96-2314-B-182-015-MY1
  • NSC96-2314-B-182-015-MY2

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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