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临床试验/NCT03080389
NCT03080389终止不适用

Are Extended Urine Cultures More Sensitive Than Standard Urine Cultures in Diagnosing Urinary Tract Infections in Patients With Urgency and Frequency?

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
16
试验地点
1
主要终点
Sensitivity of extended urine cultures compared to standard urine cultures.

研究概览

简要总结

There is some evidence to suggest standard urine cultures may not be adequate in identifying patients with low grade urinary tract infections. Therefore, there are patients with symptoms of frequency and urgency, being misdiagnosed with overactive bladder due to negative urine cultures. If this is true, could extended cultures be used to identify the false negative patients?

详细描述

In 2014, Hilt, Evann et al published a study called "Urine is not sterile," in which it was found via PCR and extended urine cultures, there is a microbiome that exists within the urinary bladder. In this study, 92% of the bacteria failed to be identified by a standard urine culture but 80% were identified with extended urine cultures. In further explorations of the significance of this microbiome, Pearce, Meghan et al. found that the female bladder consists of increased abundance of bacteria in patients with UUI; including Gardnerella and Lactobacilus gasseri. Then in 2015, a study by Thomas-White, Krystal et al. found that patients with urge urinary incontinence (UUI) who responded to treatment with Solifenacin had fewer and less diverse communities of bacteria when evaluated by PCR and extended urine cultures.

The clinical significance of the bacteria identified is not well understood. However, these studies show that the presence of bacteria is being missed by standard cultures. Dune et al. found that of patients with UTI symptoms, 27.5% were standard culture negative but extended quantitative urine culture positive. This demonstrates that practitioners may be overlooking urinary tract infections in patients with frequency and urgency. Therefore, if bacteria within the urine can be detected with extended cultures, can this technique be used to improve detection and treatment of urinary infections in patients with symptoms of frequency and urgency?

The hypotheses states that extended urine cultures are more sensitive in the identification of urinary tract infections in patients with symptoms of urgency and frequency. The secondary hypothesis is that treatment of the uropathogen identified on extended urine cultures will improve patient symptoms.

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 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 y/o-70 y/o
  • Able to consent
  • Urgency /Frequency
  • Urge incontinence
  • PUF score ≤ 4
  • Bother questionnaire #2 or #3 answered either "a moderate amount" or "a lot"

排除标准

  • Pelvic radiation
  • Chronic pelvic pain
  • Urinary retention
  • Greater than Stage 2 prolapse
  • Renal calculi
  • Recurrent UTI (2 in 6 months)
  • Immunosuppressed
  • Neurologic disorder
  • No antibiotics in the past 4 weeks

结局指标

主要结局

Sensitivity of extended urine cultures compared to standard urine cultures.

时间窗: one year

Extended urine cultures are more sensitive in the identification of urinary tract infections in patients with symptoms of urgency and frequency then standard cultures as measured by a positive urine extended culture.

次要结局

  • Treatment of uropathogens found on extended cultures result in negative repeat extended urine culture.(one year)
  • Treatment of uropathogens found on extended cultures improves urinary tract symptoms measured by the Bother and UDI-6 questionnaires(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eric Hurtado

Urogynecology Staff

The Cleveland Clinic

研究点 (1)

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