Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment (NCT04118049) | Clinical Trial Compass
CompletedNot Applicable
Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment
United States141 participantsStarted 2019-10-30
Plain-language summary
In this study, the investigators are evaluating the effect of vaginal probiotics on the bothersome side effects of pessary use and the impact on the vaginal microenvironment (lactobacilli, anaerobic bacteria, mobiluncus bacteria, WBCs, cellular debris, epithelial cells, and BVAB-1), and inflammatory environment (cytokines).
Who can participate
Age range
18 Years – 89 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:
* Postmenopausal (no menstruation \>12 months)
* Subjects presenting for 2 week post initial pessary insertion appointment or presenting for routine pessary care follow up appointment
* Planning on continuing to use a pessary for treatment for at least 3 months
* Pessary maintenance performed by provider (as opposed to self-care)
* Able to understand English
* Able/willing to sign informed consent document
Exclusion Criteria:
* Lack of cognitive ability to consent to participate in study and to complete the questionnaires
* Planned prolapse surgery less than 3 months from enrollment
* Presence of vaginal fistulas
* Pessary self-care (patient changes and cleans her own pessary)
* Receiving immunosuppressive therapy or history of immunodeficiency
* Presence of an indwelling vascular access line or structural heart disease
* Within 6 weeks from any abdominal or pelvic surgery or other major surgery
* Allergy to lactobacillus (contents of probiotic)
* Allergy to beta-lactam antibiotics, erythromycin and clindamycin
* Use of any probiotic pills, creams, or suppositories currently
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.
What they're measuring
1
Change in vaginal microenvironment
Timeframe: Vaginal specimen assessment with gram stain will be assessed upon enrollment and after 3 months of treatment.