Vaginal Microbiome-host Interaction in Mesh Exposure After TVM Surgery

The Influence of Vaginal Microbiome-host Interaction in the Mechanism of Mesh Exposure After Trans-Vaginal Mesh Implantation

Transvaginal pelvic mesh implantation（TVM） is a foreign body implantation operation with intraoperative colonization of vaginal bacteria. However, the vaginal microbiome-host interaction and its influence in the mechanism of mesh exposure after TVM remains unclear. This study will enroll post-TVM patients with and without mesh exposure and use their vaginal swabs to perform TRACE-seq and cytokine analysis. The microbiome-host interactions related with mesh exposure and the changes in protein expression will be analyzed.

Study Overview

• Status: Not yet recruiting
• Conditions: Vaginal Microbiome; Graft Versus Host Reaction

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Zhibo Zhang; Phone Number: 13693317164; Email: zzbspace@126.com
• Study Contact Backup: Name: Lan Zhu; Phone Number: 13911714696; Email: zhu_julie@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with "III-IV degree uterine/apex/anterior vaginal wall prolapse and I-II degree of posterior vaginal wall prolapse" who agree to be treated by transvaginal pelvic mesh implantation. All surgeries were performed by surgeons with extensive experience in transvaginal mesh implantation (>20 vaginal mesh implantation per year) using macroporous, monofilament, polypropylene mesh.

Description

Inclusion Criteria:

• Patients with "III-IV degree uterine/apex/anterior vaginal wall prolapse and I-II degree of posterior vaginal wall prolapse" who agree to be treated by transvaginal pelvic mesh implantation.
• All surgeries were performed by surgeons with extensive experience in transvaginal mesh implantation (>20 vaginal mesh implantation per year) using macroporous, monofilament, polypropylene mesh.

Exclusion Criteria:

• 1. Have had sex in the past 5 days or had vaginal irrigation;
• 2. Use oral or vaginal antibiotics, antifungal, immunosuppressant, hormone drugs or probiotics for the last 30 days.
• 3. Combined with immunosuppressive diseases, diseases with contraindication of vaginal estrogen such as breast cancer, endometrial cancer.
• 4. If the patient has a uterus before surgery and does not undergo total transvaginal hysterectomy during surgery,
• 5. Intraoperative bladder injury or intraoperative hemorrhage >500ml or postoperative hematoma.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with mesh exposure; During the physical examination, a speculum was inserted into the vagina to observe the vaginal epithelium for mesh exposure. If the mesh is seen on surface of the vaginal mucosa, the patient is diagnosed with mesh exposure.
Patients without mesh exposure; During the physical examination, a speculum was inserted into the vagina to observe the vaginal epithelium for mesh exposure. If the mesh is not seen on surface of the vaginal mucosa, bimanual examination will be performed to confirm no foreign body can be feeled on surface of the vaginal mucosa. Then the patient belong to this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Vaginal microbiome-host interaction in patients after TVM	Over 6 months postoperative
Vaginal microbiome-host Interaction associated with mesh exposure after TVM	Over 6 months postoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Difference of vaginal microbiome between groups	Over 6 months postoperative
Differentially expressed genes in host-mesh interaction between groups	Over 6 months postoperative

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Lan Zhu, Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2021
• Primary Completion (ANTICIPATED): September 1, 2023
• Study Completion (ANTICIPATED): September 1, 2024

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (ACTUAL): August 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 24, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: ZS-2936

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No