The Immune Reactivity of Biofilms in Vaginal Mesh Erosion.

NCT ID: NCT00564044

Last Updated: 2007-11-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2009-07-31

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

2

Group Type: ACTIVE_COMPARATOR

excision of the protruding mesh and its surrounding vaginal tissue

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Alex Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Female Pelvic Medicine and Reconstructive Surgery, Department of OB/GYN, Chang Gung Memorial Hospital

Cheng-Hsun Chiu, MD. PhD

Role: STUDY_CHAIR

Department of Pediatrics, Chang Gung Memorial Hospital

Yu-Shien Ko, MD, PhD

Role: STUDY_DIRECTOR

First Cardiovascular Division, Chang Gung Memorial Hospital

Cheng-Tao Lin, MD

Role: STUDY_DIRECTOR

Division of Gynecological Oncology, Department of OB/GYN, Chang Gung Memorial Hospital

Ren-Chin Wu, MD

Role: STUDY_DIRECTOR

Department of Surgical Pathology, Chang Gung Memorial Hospital

Tsia-Shu Lo, MD

Role: STUDY_DIRECTOR

Division of Female Pelvic Medicine and Reconstructive Surgery, Department of OB/GYN, Chang Gung Memorial Hospital

Min-Chi Chen, PhD

Role: STUDY_DIRECTOR

Biostatistics Center and Department of Public Health, Chang Gung University

Yi-Haou Lin, MD

Role: STUDY_DIRECTOR

Division of Female Pelvic Medicine and Reconstructive Surgery, Department of OB/GYN, Chang Gung Memorial Hospital

Locations

Chang Gung Memorial Hospital

Guishan, Taoyuan, Taiwan

Countries

Taiwan

Other Identifiers

NSC96-2314-B-182-015-MY1

Identifier Type: -

Identifier Source: secondary_id

NSC96-2314-B-182-015-MY2

Identifier Type: -

Identifier Source: secondary_id

NMRPD160851

Identifier Type: -

Identifier Source: org_study_id