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Assessment of Changes in Vaginal Microbiota Profiles Before and After Vaginal Urogynecologic Surgery

NCT04301401 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-13

No results posted yet for this study

Summary

Several studies have shown interactions between vaginal microbiota and post-surgical evolution. A study conducted by our team showed a tendency for patients with complications to have a greater diversity of vaginal microbiota. The main objective of the proposed study will therefore be to evaluate the vaginal, urinary and digestive microbiota modifications during and after vaginal surgery and to correlate them with the symptoms of the urogynecological sphere.

Conditions

  • Gynecological Surgery

Interventions

OTHER

Vaginal swabs

On the day of the surgical intervention, vaginal swabs will be taken at various stages of surgery: before vaginal disinfection/draping, directly after disinfection/draping, 1 hour after disinfection, 6 weeks after surgery and 12 months after surgery.

OTHER

Stool samples

Stool samples will also be taken (and collected in a pot devoted to coproculture with an airtight opaque bag given to the patient) at the inclusion visit on the day before surgery and also 6 weeks after surgery (in a second pot with an airtight opaque bag given to the patient at the time of being discharged).

OTHER

Urine samples

Urine samples will also be taken before surgery and 6 weeks after surgery.

Sponsors & Collaborators

  • Nantes University Hospital

    collaborator OTHER

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2023-01-18
Completion
2023-10-10

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04301401 on ClinicalTrials.gov