Host Response to Pessaries in Microbial Communities of the Postmenopausal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Predominant vaginal microorganisms of older women with and without a pessary
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 51 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Predominant vaginal microorganisms of older women with and without a pessary
时间窗: 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).
次要结局
- Vaginal antimicrobial peptide (AMP) profile of older women with and without a pessary.(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.(3 month visit, 6 month visit)
研究者
Cynthia Brincat
M.D., Ph.D.
Loyola University