The Immune Reactivity of Biofilms in Vaginal Mesh Erosion.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Chang Gung Memorial Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00564044
First received: November 25, 2007
Last updated: November 26, 2007
Last verified: August 2007
  Purpose

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.


Condition Intervention
Uterine Prolapse
Urinary Incontinence
Fecal Incontinence
Procedure: excision of the protruding mesh and its surrounding vaginal tissue

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Does the Immune Reactivity of Bacteria Cause Vaginal Mesh (Polypropylene) Erosion? - A Ultrastructural, Microbiological and Immunohistochemical Analysis.

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 82
Study Start Date: August 2007
Estimated Study Completion Date: July 2009
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00564044

Locations
Taiwan
Chang Gung Memorial Hospital
Gueishan, Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00564044     History of Changes
Other Study ID Numbers: NMRPD160851, NSC96-2314-B-182-015-MY1, NSC96-2314-B-182-015-MY2
Study First Received: November 25, 2007
Last Updated: November 26, 2007
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
biofilm-infection-related immune hyperreactivity
mesh extrusion
mid-urethral sling
determine the immune reactivity of biofilms in mesh erosion

Additional relevant MeSH terms:
Fecal Incontinence
Prolapse
Urinary Incontinence
Uterine Prolapse
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Uterine Diseases
Genital Diseases, Female
Pelvic Organ Prolapse

ClinicalTrials.gov processed this record on July 20, 2014