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Completed

NCT Number: NCT02605135

Host Response to Pessaries in Microbial Communities of the Postmenopausal Vagina

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.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

51 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continued Pessary Use

Device

Pessary Fitting

Primary outcomes

  1. Predominant vaginal microorganisms of older women with and without a pessary

    Time frame: 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 outcomes

  1. Vaginal antimicrobial peptide (AMP) profile of older women with and without a pessary.

    Time frame: 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).

  2. 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Registry information

Official study title

Host Response to Pessaries in Microbial Communities of the Postmenopausal

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Nov 16, 2015
Registry last updated
Jan 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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