Status:
COMPLETED
Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment
Lead Sponsor:
Hartford Hospital
Collaborating Sponsors:
University of Maryland
University of Connecticut
Conditions:
Pelvic Organ Prolapse
Inflammatory Response
Eligibility:
FEMALE
18-89 years
Phase:
NA
Brief 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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2021
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT04118049
Start Date
October 30 2019
End Date
May 30 2021
Last Update
March 25 2022
Active Locations (1)
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1
Hartford Hospital
Hartford, Connecticut, United States, 06103