Assessment of Changes in Vaginal Microbiota Profiles Before and After Vaginal Urogynecologic Surgery (NCT04301401) | Clinical Trial Compass
CompletedNot Applicable
Assessment of Changes in Vaginal Microbiota Profiles Before and After Vaginal Urogynecologic Surgery
France60 participantsStarted 2020-03-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.