Host Response to Pessaries in Microbial Communities of the Postmenopausal Vagina
Study Details
Study Description
Brief Summary
The ability to determine the postmenopausal vaginal environment and the impact of pessary use could help to maximize pessary therapy and non-surgical treatment for such a prevalent problem.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The study will advance the care of elderly patients through providing data to maximize non-surgical options to those at high risk for having surgery and its attending morbidity. In characterizing substantive differences in the vaginal environment of successful and unsuccessful pessary users, the investigators can identify elderly patients at higher risk of adverse events with pessary use as well as novel targets for the pharmacologic treatment of the altered vaginal microbiota and endogenous AMP levels, potentially allowing patients to continue with non-surgical therapies rather than pursuing surgical intervention.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Device: 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. |
Device: Continued Pessary Use
Pessary Fitting
|
Outcome Measures
Primary Outcome Measures
- Predominant vaginal microorganisms of older women with and without a pessary [Baseline]
The investigator will collect a vaginal swab specimen in an aerobic and anaerobic preservative tube. Specimens will be sent to the clinical microbiology lab for quantitative culture. Expanded quantitative vaginal culture techniques and matrix assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS).
Secondary Outcome Measures
- Vaginal antimicrobial peptide (AMP) profile of older women with and without a pessary. [Baseline]
The investigator will collect vaginal lavage fluid (VLF) prior to pessary placement and after vaginal swabs are obtained. Assessing AMP activity using high pressure liquid chromatography fractionation and radial diffusion assay to assess for AMP activity and abundance of candidate AMPs (cathelicidin, beta defensisn (hBD1 and hBD2) psoriasin, lactoferrin).
- Vaginal microbiome and AMP profile between those women that choose to continue pessary use and those that do not by correlating the data from Aim 1 and Aim 2 with the clinical characteristic of continued pessary use. [3 month visit, 6 month visit]
The investigator will collect vaginal swabs and the Vaginal Lavage Fluid for those subjects who decide to NOT have their pessaries replaced by correlating the data from outcome 1 and outcome 2 with the clinical characteristic of continued pessary use.
Eligibility Criteria
Criteria
Inclusion Criteria:
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must be English speaking
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appropriate for pessary treatment
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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:
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a history of current, symptomatic vaginal stricture
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a history of current, radiation therapy,
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or current treatment with auto-immune suppression agents.
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if they have eroded mesh in the vagina from prior pelvic floor surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
Sponsors and Collaborators
- Loyola University
Investigators
- Principal Investigator: Cynthia Brincat, MD, Loyola University
Study Documents (Full-Text)
None provided.More Information
Publications
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