Host Response to Pessaries in Microbial Communities of the Postmenopausal Vagina
NCT ID: NCT02605135
Last Updated: 2019-01-22
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
84 participants
OBSERVATIONAL
2016-04-30
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Continued Pessary Use
All participants will undergo clinical testing prior to placement of the pessary and the investigator will test their vaginal environment prior to pessary placement. Testing will consists of a vaginal swab and 10 mL of vaginal lavage at each study visit. The participant will then be followed, and repeat testing obtained at the standard clinical interval for pessary follow-up, every three months
Continued Pessary Use
Pessary Fitting
Discontinued Pessary Use
All participants will undergo clinical testing prior to placement of the pessary and the investigator will test their vaginal environment prior to pessary placement. Testing will consists of a vaginal swab (AIM 1) and 10 mL of vaginal lavage (Aim 2) at each study visit. The participant will then be followed, and repeat testing obtained at the standard clinical interval for pessary follow-up, every three months. Should the participant discontinue pessary use, we will additionally culture the microbes that are present on the pessary and compare those to the vaginal microbiota.
Continued Pessary Use
Pessary Fitting
Interventions
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Continued Pessary Use
Pessary Fitting
Eligibility Criteria
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Inclusion Criteria
* appropriate for pessary treatment
* pelvic floor conditions such as POP (with or without the presence of a uterus), stress urinary incontinence, urge urinary incontinence, or any combination of the above.
Exclusion Criteria
* a history of current, radiation therapy,
* or current treatment with auto-immune suppression agents.
* if they have eroded mesh in the vagina from prior pelvic floor surgery
51 Years
FEMALE
No
Sponsors
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Loyola University
OTHER
Responsible Party
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Cynthia Brincat
M.D., Ph.D.
Principal Investigators
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Cynthia Brincat, MD
Role: PRINCIPAL_INVESTIGATOR
Loyola University
Locations
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Loyola University Medical Center
Maywood, Illinois, United States
Countries
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References
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Other Identifiers
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207001
Identifier Type: -
Identifier Source: org_study_id
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