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

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Gynecological Surgery

Treatments

Other: Vaginal swabs

Other: Stool samples

Other: Urine samples

Study type

Interventional

Funder types

Other

Identifiers

NCT04301401

NIMAO/2019-01/LA-01

Details and patient eligibility

About

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.

Full description

In gynecological surgery, surgical site infections are a common complication. Gynecological surgery and, more specifically, vaginal surgery leads to a high risk of infection not only due to its " clean-contaminated " nature related to the proximity of the vagina but also due to the use of a transvaginal mesh or suburetal sling. The germs most commonly found at the origin of a surgical site infection are germs forming part of the vaginal flora.

Furthermore, in the field of pelvic organ prolapse surgery, certain specific complications such as mesh retraction and mesh exposure may be related to infection due to bacterial colonisation.

The vaginal ecosystem contains a large quantity of bacteria, the commonest of which are lactobacilli. This ecosystem varies in women depending on their sexuality, hormonal impregnation, tobacco consumption or hygiene.It has been demonstrated that the microbiota can be divided into 7 classes depending on the predominant types of germ. It has also been shown that an imbalance in vaginal flora could be responsible for infections of the upper genital tract, obstetric complications or even the transmission of sexually transmissible diseases.

Several studies have shown interactions between the microbiota and post surgical evolution. A recent study carried out at the Gynecology and Obstetrics department of Nîmes University Hospital (Veit Rubin et al, NAU 2019) also investigated the relationship between vaginal microbiota and the onset of postoperative complications in transvaginal mesh surgery. This retrospective study also found that patients with complications tended to have a greater diversity of microbiota. Furthermore, certain species of bacteria (Veillonella spp) seemed to be commoner in patients with complications. However, this was a low-powered retrospective study with few participants and the results therefore need to be confirmed.

Our hypothesis is that the vaginal microbiota may be modified by a surgical act with a vaginal approach. There are very few studies on vaginal microbiota and so far no studies have evaluated the potential impact of a transvaginal surgery on vaginal microbiota.

Our study may help to better understand the relationship between the vaginal microbiota and the postoperative evolution of patients.These possible modifications in vaginal microbiota might be predictive of the symptomatology of patients benefitting from transvaginal surgery and play a role in the the post-operative evolution of these patients.

Enrollment

60 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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 in an exclusion period determined by another study
Patients under court custody, guardianship or curatorship
Patients for whom it has been impossible to give clear information