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

NCT04301401 | Completed

• 1 other identifier: NIMAO/2019-01/LA-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Microbiota; vagina; prolapse; transvaginal surgery; surgical site infection

Outcome Measures

Primary Outcomes (2)

• Classes of vaginal flora before surgery

  A vaginal swab will be taken before surgery and the sample will be analyzed by DNA sequencing in order to classify the microbiota into community state types.

  Day 1

• Classes of vaginal flora 6 weeks after surgery

  A vaginal swab will be taken 6 weeks after surgery and the sample will be analyzed by DNA sequencing in order to classify the microbiota into community state types.

  Day 42

Secondary Outcomes (39)

• Classes of vaginal flora 12 mois after surgery

  Month 12

• Alphadiversity of vaginal flora before preparation for surgery measured with the Shannon index

  Day 1

• Betadiversity of vaginal flora before preparation for surgery measured with the Bray-Curtis index

  Day 1

• Alphadiversity of vaginal flora directly after disinfection and draping, measured with the Shannon index

  Day 1

• Betadiversity of vaginal flora directly after disinfection and draping, measured with the Bray-Curtis index

  Day 1

Study Arms (1)

Patients being evaluated for changes in microbiota

EXPERIMENTAL

Patients being evaluated for changes in vaginal microbiota following transvaginal surgery.

Other: Vaginal swabs; Other: Stool samples; Other: Urine samples

Interventions

Vaginal swabs OTHER

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.

Patients being evaluated for changes in microbiota

Stool samples OTHER

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).

Patients being evaluated for changes in microbiota

Urine samples OTHER

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

Patients being evaluated for changes in microbiota

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Menopausal women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Caucasian menopausal women (not taking hormone substitutes)
• Due to undergo transvaginal surgery (as a cure for pelvic organ prolapse or stress urinary incontinence surgery) from the Gynecology departments of Nantes and Nîmes University Hospitals.
• Patients must be covered by a health insurance policy
• Patients must have given written, informed consent.

You may not qualify if:

• Patients on recent (\<1 month) immunosuppressive therapy,
• Patients with ongoing antibiotic therapy,
• Patients with chronic vaginosis,
• Patients on hormone replacement therapy
• Patients who have had previous transvaginal mesh surgery.
• Patients taking part in another category 1 study for research involving human subjects.
• Patients under court custody, guardianship or curatorship
• Patients for whom it has been impossible to give clear information

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• Nantes University Hospital: collaborator

Study Sites (1)

Centre Hospitalier Universitaire

Nîmes, Gard, 30000, France

Location

Related Publications (1)

• Zhang Y, Allegre L, Salipante F, Morsli M, Thubert T, Lavigne JP, Dunyach-Remy C, de Tayrac R. Impact of surgical field disinfection on vaginal microbiome in transvaginal urogynecological surgery: a prospective cohort study. Antimicrob Resist Infect Control. 2025 Aug 26;14(1):102. doi: 10.1186/s13756-025-01622-6.

  PMID: 40859385 RESULT

MeSH Terms

Conditions

Prolapse; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Wound Infection; Infections; Postoperative Complications; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 10, 2020
• Study Start: March 1, 2020
• Primary Completion: January 18, 2023
• Study Completion: October 10, 2023
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

FR (1)