Gynecological SurgeryVAGIBIOTENCT04301401
Assessment of Changes in Vaginal Microbiota Profiles Before and After Vaginal Urogynecologic Surgery
A study testing Vaginal swabs, Stool samples and Urine samples in people with Gynecological Surgery, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecological Surgery
- What is being tested?
- Vaginal swabs, Stool samples and Urine samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 10 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Gynecological Surgery
- Being tested
- Vaginal swabs, Stool samples, Urine samples
- Keywords
- Microbiota, vagina, prolapse, transvaginal surgery, surgical site infection
- Medical subject headings
- Prolapse, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal swabsOther
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 samplesOther
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 samplesOther
Urine samples will also be taken before surgery and 6 weeks after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Patients being evaluated for changes in microbiota | Experimental | Patients being evaluated for changes in vaginal microbiota following transvaginal surgery. Receives: Other: Vaginal swabs; Other: Stool samples; Other: Urine samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 42
Secondary outcomes (39)
Classes of vaginal flora 12 mois after surgery
A vaginal swab will be taken 12 months after surgery and the sample will be analyzed by DNA sequencing in order to classify the microbiota into community state types.
Measured: Month 12
Alphadiversity of vaginal flora before preparation for surgery measured with the Shannon index
A vaginal swab will be taken before any preparation for surgery has begun and the alphadiversity of the microbiota will be measured according to the Shannon index in Taxonomic Operational Units
Measured: Day 1
Betadiversity of vaginal flora before preparation for surgery measured with the Bray-Curtis index
A vaginal swab will be taken before any preparation for surgery has begun and the betadiversity of the microbiota will be measured according to the Bray-Curtis index in Taxonomic Operational Units
Measured: Day 1
Alphadiversity of vaginal flora directly after disinfection and draping, measured with the Shannon index
A vaginal swab will be taken directly after disinfection and draping and the alphadiversity of the microbiota will be measured according to the Shannon index in Taxonomic Operational Units.
Measured: Day 1
Betadiversity of vaginal flora directly after disinfection and draping, measured with the Bray-Curtis index
A vaginal swab will be taken directly after disinfection and draping and the betadiversity of the microbiota will be measured according to the Bray-Curtis index in Taxonomic Operational Units.
Measured: Day 1
Alphadiversity of vaginal flora one hour after disinfection and draping, measured with the Shannon index
A vaginal swab will be taken one hour after disinfection and draping and the alphadiversity of the microbiota will be measured according to the Shannon index in Taxonomic Operational Units.
Measured: Day 1
Betadiversity of vaginal flora one hour after disinfection and draping, measured with the Bray-Curtis index
A vaginal swab will be taken one hour after disinfection and draping and the betadiversity of the microbiota will be measured according to the Bray-Curtis index in Taxonomic Operational Units.
Measured: Day 1
Alphadiversity of vaginal flora six weeks after surgery, measured with the Shannon index
A vaginal swab will be taken six weeks after surgery and the alphadiversity of the microbiota will be measured according to the Shannon index in Taxonomic Operational Units.
Measured: Day 42
Betadiversity of vaginal flora six weeks after surgery, measured with the Bray-Curtis index
A vaginal swab will be taken six weeks after surgery and the betadiversity of the microbiota will be measured according to the Bray-Curtis index in Taxonomic Operational Units.
Measured: Day 42
Alphadiversity of vaginal flora twelve months after surgery, measured with the Shannon index
A vaginal swab will be taken twelve months after surgery and the alphadiversity of the microbiota will be measured according to the Shannon index in Taxonomic Operational Units.
Measured: Month 12
Betadiversity of vaginal flora twelve months after surgery, measured with the Bray-Curtis index
A vaginal swab will be taken twelve months after surgery and the betadiversity of the microbiota will be measured according to the Bray-Curtis index in Taxonomic Operational Units.
Measured: Month 12
Prolapse. Feeling a bulge six weeks after surgery
Yes/No. If present, this will be classified according to the International Continence Society-International Urogynecological Association classification
Measured: Day 42
Prolapse. Feeling a bulge twelve months after surgery
Yes/No. If present, this will be classified according to the International Continence Society-International Urogynecological Association classification
Measured: Month 12
Dyspareunia six weeks after surgery
Yes/no. If present, this will be rated according to the International Continence Society-International Urogynecological Association classification.
Measured: Day 42
Dyspareunia 12 months after surgery
Yes/No. If present, this will be rated according to the International Continence Society-International Urogynecological Association classification.
Measured: Month 12
Pain six weeks after surgery
The patient will be asked to evaluate pain according to a visual analogue scale ranging from 0 (no pain) to 10 (extremely painful).
Measured: Day 42
Pain 12 months after surgery
The patient will be asked to evaluate pain according to a visual analogue scale ranging from 0 (no pain) to 10 (extremely painful).
Measured: Month 12
Urinary incontinence upon effort six weeks after surgery
Yes/No. If present, this will be rated according to the International Continence Society-International Urogynecological Association classification.
Measured: Day 42
Urinary incontinence upon effort 12 months after surgery
Yes/No.If present, this will be classified according to the International Continence Society-International Urogynecological Association classification
Measured: Month 12
Need to urinate urgently six weeks after surgery
Yes/No.If present, this will be classified according to the International Continence Society-International Urogynecological Association classification.
Measured: Day 42
Need to urinate urgently 12 months after surgery
Yes/No.If present, this will be classified according to the International Continence Society-International Urogynecological Association classification.
Measured: Month 12
Dysuria 6 weeks after surgery
Yes/No.If present, this will be classified according to the International Continence Society-International Urogynecological Association classification.
Measured: Day 42
Dysuria 12 months after surgery
Yes/No.If present, this will be classified according to the International Continence Society-International Urogynecological Association classification.
Measured: Month 12
Constipation 6 weeks after surgery
Yes/No. If present, this will be classified according to the International Continence Society-International Urogynecological Association classification.
Measured: Day 42
Constipation 12 months after surgery
Yes/No. If present, this will be classified according to the International Continence Society-International Urogynecological Association classification.
Measured: Month 12
Anal incontinence 6 weeks after surgery
Yes/No. If present, this will be classified according to the International Continence Society-International Urogynecological Association classification.
Measured: Day 42
Anal incontinence 12 months after surgery
Yes/No. If present, this will be classified according to the International Continence Society-International Urogynecological Association classification.
Measured: Month 12
Presence or absence of complications 6 weeks after surgery
Yes/No. If present, these will be rated according to the Clavien Dindo classification. The Clavien Dindo classification is a scale with grades ranging from 1 to 5 in which Grade 1 = any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside. Grade 5 = death of the patient.
Measured: Day 42
Presence or absence of complications 12 months after surgery
Yes/No. If present, these will be rated according to the Clavien Dindo classification.The Clavien Dindo classification is a scale with grades ranging from 1 to 5 in which Grade 1 = any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside. Grade 5 = death of the patient.
Measured: Month 12
Presence or absence of complications related to a prosthesis 6 weeks after surgery
Yes/No. If present, these will be rated according to the International Continence Society-International Urogynecological Association classification
Measured: Day 42
Presence or absence of complications related to a prosthesis 12 months after surgery
Yes/No. If present, these will be rated according to the International Continence Society-International Urogynecological Association classification.
Measured: Month 12
Presence or absence of infection at the operating site 6 weeks after surgery
Yes/No
Measured: Day 42
Presence or absence of infection at the operating site 12 months after surgery
Yes/No
Measured: Month 12
Urine sample before surgery
A urine sample will be collected from the patient before surgery and stored in a sterile pot at -80° at the Biological resource Centre at Nîmes or Nantes University Hospitals.
Measured: Day 1
Urine sample after vaginal disinfection and surgical draping.
A urine sample will be collected from the patient before surgery but after vaginal disinfection and surgical draping, and stored in a sterile pot at -80° at the Biological resource Centre at Nîmes or Nantes University Hospitals.
Measured: Day 1
Urine sample 6 weeks after surgery six weeks after surgery
A urine sample will be collected from the patient 6 weeks after surgery and stored in a sterile pot at -80° at the Biological resource Centre at Nîmes or Nantes University Hospitals.
Measured: Day 42
Urine sample 12 months after surgery
A urine sample will be collected from the patient 12 months after surgery and stored in a sterile pot at -80° at the Biological resource Centre at Nîmes or Nantes University Hospitals.
Measured: Month 12
Stool sample before surgery
The day before surgery, at the inclusion visit, a stool sample will be collected in a sterile pot and stored at -80° at the Biological resource Centre at Nîmes or Nantes University Hospitals.
Measured: Day 0
Stool sample 6 weeks after surgery
Six weeks after surgery, a stool sample will be collected in a sterile pot and stored at -80° at the Biological resource Centre at Nîmes or Nantes University Hospitals.
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Mar 2020
- Primary completion18 Jan 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecological SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- Nantes University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301401
- Sponsor's protocol ID
- NIMAO/2019-01/LA-01
- Acronym
- VAGIBIOTE
- Status last verified
- Jan 2026
- First submitted
- 6 Mar 2020
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40859385
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Changes in Vaginal Microbiota Profiles Before and After Vaginal Urogynecologic Surgery
- ClinicalTrials.gov ID
- NCT04301401
- Acronym / sponsor ID
- VAGIBIOTE / NIMAO/2019-01/LA-01
- Conditions
- Gynecological Surgery
- Keywords
- Microbiota, vagina, prolapse, transvaginal surgery, surgical site infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- Nantes University Hospital
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients being evaluated for changes in microbiota | Experimental | Other: Vaginal swabs, Other: Stool samples, Other: Urine samplesPatients being evaluated for changes in vaginal microbiota following transvaginal surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal swabsOn 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 | Patients being evaluated for changes in microbiota |
| Stool samplesStool 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 | Patients being evaluated for changes in microbiota |
| Urine samplesUrine samples will also be taken before surgery and 6 weeks after surgery. | Other | Patients being evaluated for changes in microbiota |
Primary outcome
Classes of vaginal flora before surgery
Time frame: Day 1
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.
Classes of vaginal flora 6 weeks after surgery
Time frame: Day 42
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.
39 secondary outcomes
Classes of vaginal flora 12 mois after surgery
Time frame: Month 12
Alphadiversity of vaginal flora before preparation for surgery measured with the Shannon index
Time frame: Day 1
Betadiversity of vaginal flora before preparation for surgery measured with the Bray-Curtis index
Time frame: Day 1
Alphadiversity of vaginal flora directly after disinfection and draping, measured with the Shannon index
Time frame: Day 1
Betadiversity of vaginal flora directly after disinfection and draping, measured with the Bray-Curtis index
Time frame: Day 1
Alphadiversity of vaginal flora one hour after disinfection and draping, measured with the Shannon index
Time frame: Day 1
Betadiversity of vaginal flora one hour after disinfection and draping, measured with the Bray-Curtis index
Time frame: Day 1
Alphadiversity of vaginal flora six weeks after surgery, measured with the Shannon index
Time frame: Day 42
Betadiversity of vaginal flora six weeks after surgery, measured with the Bray-Curtis index
Time frame: Day 42
Alphadiversity of vaginal flora twelve months after surgery, measured with the Shannon index
Time frame: Month 12
Betadiversity of vaginal flora twelve months after surgery, measured with the Bray-Curtis index
Time frame: Month 12
Prolapse. Feeling a bulge six weeks after surgery
Time frame: Day 42
Prolapse. Feeling a bulge twelve months after surgery
Time frame: Month 12
Dyspareunia six weeks after surgery
Time frame: Day 42
Dyspareunia 12 months after surgery
Time frame: Month 12
Pain six weeks after surgery
Time frame: Day 42
Pain 12 months after surgery
Time frame: Month 12
Urinary incontinence upon effort six weeks after surgery
Time frame: Day 42
Urinary incontinence upon effort 12 months after surgery
Time frame: Month 12
Need to urinate urgently six weeks after surgery
Time frame: Day 42
Need to urinate urgently 12 months after surgery
Time frame: Month 12
Dysuria 6 weeks after surgery
Time frame: Day 42
Dysuria 12 months after surgery
Time frame: Month 12
Constipation 6 weeks after surgery
Time frame: Day 42
Constipation 12 months after surgery
Time frame: Month 12
Anal incontinence 6 weeks after surgery
Time frame: Day 42
Anal incontinence 12 months after surgery
Time frame: Month 12
Presence or absence of complications 6 weeks after surgery
Time frame: Day 42
Presence or absence of complications 12 months after surgery
Time frame: Month 12
Presence or absence of complications related to a prosthesis 6 weeks after surgery
Time frame: Day 42
Presence or absence of complications related to a prosthesis 12 months after surgery
Time frame: Month 12
Presence or absence of infection at the operating site 6 weeks after surgery
Time frame: Day 42
Presence or absence of infection at the operating site 12 months after surgery
Time frame: Month 12
Urine sample before surgery
Time frame: Day 1
Urine sample after vaginal disinfection and surgical draping.
Time frame: Day 1
Urine sample 6 weeks after surgery six weeks after surgery
Time frame: Day 42
Urine sample 12 months after surgery
Time frame: Month 12
Stool sample before surgery
Time frame: Day 0
Stool sample 6 weeks after surgery
Time frame: Day 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Results publication: PubMed 40859385Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal swabs, Stool samples and Urine samples in people with Gynecological Surgery, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classes of vaginal flora before surgery (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04301401, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.