Assessment of Changes in Vaginal Microbiota Profiles Before and After Vaginal Urogynecologic Surgery
NCT ID: NCT04301401
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2020-03-01
2023-10-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Patients being evaluated for changes in microbiota
Patients being evaluated for changes in vaginal microbiota following transvaginal surgery.
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.
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).
Urine samples
Urine samples will also be taken before surgery and 6 weeks after surgery.
Interventions
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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.
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).
Urine samples
Urine samples will also be taken before surgery and 6 weeks after surgery.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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Nantes University Hospital
OTHER
Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Locations
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Centre Hospitalier Universitaire
Nîmes, Gard, France
Countries
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References
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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.
Other Identifiers
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NIMAO/2019-01/LA-01
Identifier Type: -
Identifier Source: org_study_id
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