Vaginal Microbiome-host Interaction in Mesh Exposure After TVM Surgery

Vaginal Microbiome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05000112
• Other study ID #: ZS-2936
• Status: Not yet recruiting
• Start date: September 2021
• Est. completion date: September 2024

Study information

• Verified date: July 2021
• Source: Peking Union Medical College Hospital
• Contact: Zhibo Zhang
• Phone: 13693317164
• Email: zzbspace[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vaginal Microbiome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal microbiome-host interaction in patients after TVM		Over 6 months postoperative
Primary	Vaginal microbiome-host Interaction associated with mesh exposure after TVM		Over 6 months postoperative
Secondary	Difference of vaginal microbiome between groups		Over 6 months postoperative
Secondary	Differentially expressed genes in host-mesh interaction between groups		Over 6 months postoperative