Trends in the Microbiome Profiles of Women With Urgency and Frequency Syndrome, With or Without Pelvic Pain?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Proportion of patients negative for repeat sequencing.
研究概览
简要总结
To determine differences in the urinary microbiomes, identified by polymerase change reaction (PCR) (UTIP™), of female patients with urgency and frequency syndrome with or without pelvic pain (Group A) compared to female controls without symptoms of lower urinary tract symptoms (LUTS) (Group B).
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 y/o-90 y/o
- •Able to consent
- •Group A only: Urgency and Frequency Syndrome or OAB only. UDI-6 answer of "moderately" to "quite a bit" on questions 1 or
- •Group B only: Urinary Distress Inventory 6 (UDI-6) answer "not at all" or "somewhat" for questions 1 or 2.
排除标准
- •Pelvic radiation
- •Urinary retention (>200 ml)
- •Renal calculi
- •Recurrent urinary tract infection (UTI) (2 in 6 months), or
- •Current UTI
- •Immunosuppressed or radiation history
- •Neurologic disorder
结局指标
主要结局
Proportion of patients negative for repeat sequencing.
时间窗: Day 1
Evaluation of urine and perineal samples by PCR.
Proportion of patients with change in UDI-6 score
时间窗: Up to 4 weeks
UDI 6 question 1 and 2 has a total score from 0-6 with a high score indicating more distress. Proportion of patients with a decrease in score from baseline will be reported for this outcome.
Proportion of patients with Lactobacillus in samples.
时间窗: Day 1
Evaluation of urine and perineal samples by PCR.
次要结局
未报告次要终点
研究者
Laura Martin
Assistant Professor
University of Miami