Clinical trial NCT02605135: Host Response to Pessaries in Microbial Communities of the Postmenopausal Vagina
Official title: Host Response to Pessaries in Microbial Communities of the Postmenopausal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence
Prolapse
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2015-11-16
Enrollment: 84
Sex: FEMALE
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects must be female, postmenopausal, and have symptomatic pelvic floor disorders as evidenced by presenting to our tertiary care clinic.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Predominant vaginal microorganisms of older women with and without a pessary
timeFrame: Baseline
Secondary outcomes:
measure: Vaginal antimicrobial peptide (AMP) profile of older women with and without a pessary.
timeFrame: Baseline
measure: 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.
timeFrame: 3 month visit, 6 month visit
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
affiliation: Loyola University
name: Cynthia Brincat, MD
role: PRINCIPAL_INVESTIGATOR
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