The Immune Reactivity of Biofilms in Vaginal Mesh Erosion.

NCT00564044 | Unknown

• 3 other identifiers: NMRPD160851NSC96-2314-B-182-015-MY1NSC96-2314-B-182-015-MY2
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• To determine whether bacterial infection with biofilm formation exists in the vaginal tissue with mesh extrusion using bacterial culture and electron microscopic analysis.

  3 years

Secondary Outcomes (1)

• 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.

  3 years

Study Arms (1)

2

ACTIVE COMPARATOR

Procedure: excision of the protruding mesh and its surrounding vaginal tissue

Interventions

excision of the protruding mesh and its surrounding vaginal tissue 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.

2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Guishan, Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Uterine Prolapse; Urinary Incontinence; Fecal Incontinence

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Alex Wang, MD

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

  PRINCIPAL INVESTIGATOR

• Cheng-Hsun Chiu, MD. PhD

  Department of Pediatrics, Chang Gung Memorial Hospital

  STUDY CHAIR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 25, 2007
• First Posted: November 27, 2007
• Study Start: August 1, 2007
• Study Completion: July 1, 2009
• Last Updated: November 27, 2007

Record last verified: 2007-08

Locations

TW (1)