Vaginal Microbiome-host Interaction in Mesh Exposure After TVM Surgery

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Not yet enrolling

Conditions: Graft Versus Host Reaction; Vaginal Microbiome

Study type: Observational

Funder types: Other

Identifiers

NCT05000112

ZS-2936

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 45 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 2 patient groups

Patients with mesh exposure

Description:

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

Description:

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.