Host Response to Pessaries in Microbial Communities of the Postmenopausal Vagina

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Host Response to Pessaries in Microbial Communities of the Postmenopausal

Conditions
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Stress Urinary Incontinence, Prolapse

Intervention / Treatment
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* Device: Continued Pessary Use


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: must be English speaking 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, symptomatic vaginal stricture 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

Ages Eligible for Study
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Minimum Age: 51 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Continued Pessary Use<br>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<br>* Pessary Fitting<br>|
| Discontinued Pessary Use<br>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<br>* Pessary Fitting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predominant vaginal microorganisms of older women with and without a pessary | 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). | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal antimicrobial peptide (AMP) profile of older women with and without a pessary. | 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). | Baseline | 
| 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. | 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. | 3 month visit, 6 month visit |