Midstream Urine Collection Device Compared to Catheterized Sample: Contamination and Patient Satisfaction.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Contamination of urine specimen with urethral and vaginal flora
研究概览
简要总结
Urine culture and microscopic urinalysis will be compared between 2 collection methods: PEEZY midstream urine collection, and urethral catheter collection.
详细描述
Female patients presenting to the Baylor Scott & White Health (Temple, TX) Urology clinic for complaints of lower urinary tract symptoms will be included. They will be approached by a clinical research coordinator and given more information. If they meet eligibility by screening, consents will be completed.
Patients will proceed with their regular clinic visit with their clinician. Just prior to the physical exam, patients will use the PEEZY device to give a urine specimen in the privacy of the bathroom. The package with PEEZY includes the simple instructions for use. Patients return to the clinic room and the physical exam proceeds. An in-and-out catheter is used to obtain a post-void residual as well as a control urine specimen. After the remainder of the patient routine exam is complete, they will fill out a brief questionnaire.
The 2 specimens will then be delivered to the lab. The clinical research coordinator will store consents and questionnaires that include the subjects study identification number in individual opaque envelopes that will be kept in a locked drawer accessible to only the investigators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females presenting to the Urology or Urogynecology clinic for consultation or evaluation of lower urinary tract complaints.
排除标准
- •Known pregnancy
- •Use of antimicrobial oral or vaginal therapy in the past 4 weeks
- •Use of Pyridium in the past 4 weeks
研究组 & 干预措施
PEEZY specimen
All subjects will use PEEZY to give a urine specimen.
干预措施: Midstream urine collection device (Device)
CATHETER specimen
All subjects will use CATHETER (performed by their clinician) to give a urine specimen, following PEEZY use.
干预措施: Catheter for urine collection (Device)
结局指标
主要结局
Contamination of urine specimen with urethral and vaginal flora
时间窗: 2 specimens from each subject (1 from each arm) will be taken to the lab for urinalysis and culture immediately after specimens are given. Culture results will be reported in 48 hours. After results are recorded, no further assessment of this outcome.
Contamination defined as: presence of urethral or vaginal flora on urine culture OR epithelial cell presence in urinalysis
次要结局
- Visual Analog Scale (this is the only title for this scale)(Performed one time immediately after intervention. This will not be repeated.)