Clinical trial NCT00564044: The Immune Reactivity of Biofilms in Vaginal Mesh Erosion.
Official title: Does the Immune Reactivity of Bacteria Cause Vaginal Mesh (Polypropylene) Erosion? - A Ultrastructural, Microbiological and Immunohistochemical Analysis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterine Prolapse
Urinary Incontinence
Fecal Incontinence
Keywords: biofilm-infection-related immune hyperreactivity
mesh extrusion
mid-urethral sling
determine the immune reactivity of biofilms in mesh erosion
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2007-11-27
Enrollment: 82
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: To determine whether bacterial infection with biofilm formation exists in the vaginal tissue with mesh extrusion using bacterial culture and electron microscopic analysis.
timeFrame: 3 years
Secondary outcomes:
measure: 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.
timeFrame: 3 years
Other outcomes:
Locations:
city: Gueishan
country: Taiwan
facility: Chang Gung Memorial Hospital
state: Taoyuan
Study officials:
affiliation: Division of Female Pelvic Medicine and Reconstructive Surgery, Department of OB/GYN, Chang Gung Memorial Hospital
name: Alex Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pediatrics, Chang Gung Memorial Hospital
name: Cheng-Hsun Chiu, MD. PhD
role: STUDY_CHAIR
affiliation: First Cardiovascular Division, Chang Gung Memorial Hospital
name: Yu-Shien Ko, MD, PhD
role: STUDY_DIRECTOR
affiliation: Division of Gynecological Oncology, Department of OB/GYN, Chang Gung Memorial Hospital
name: Cheng-Tao Lin, MD
role: STUDY_DIRECTOR
affiliation: Department of Surgical Pathology, Chang Gung Memorial Hospital
name: Ren-Chin Wu, MD
role: STUDY_DIRECTOR
affiliation: Division of Female Pelvic Medicine and Reconstructive Surgery, Department of OB/GYN, Chang Gung Memorial Hospital
name: Tsia-Shu Lo, MD
role: STUDY_DIRECTOR
affiliation: Biostatistics Center and Department of Public Health, Chang Gung University
name: Min-Chi Chen, PhD
role: STUDY_DIRECTOR
affiliation: Division of Female Pelvic Medicine and Reconstructive Surgery, Department of OB/GYN, Chang Gung Memorial Hospital
name: Yi-Haou Lin, MD
role: STUDY_DIRECTOR
References: