o Wipe or Not To Wipe?: That Is The Question
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Rate of Contamination
研究概览
简要总结
The primary aim of this randomized control trial is to characterize whether a mid-stream clean catch sample using a cleansing wipe in the setting of symptomatic UTI in a female patient is associated with a lower rate of contamination. We hypothesize that using a perineal cleansing wipe at the time of a midstream urine sample will decrease rates of contamination for female patients with a symptomatic UTI.
详细描述
The primary aim of this study is to determine whether using a perineal cleansing wipe decreases the rate of a contaminated midstream clean catch sample in female patients with a symptomatic UTI.
This is a single-blind, randomized controlled trial comparing the use of a perineal cleansing wipe versus no wipe in adult female patients who present to the urology clinic at IRL or 3RC with a symptomatic UTI.
Following IRB approval, patients who are eligible for the study (female patients >18 years of age with active UTI symptoms) will be asked to participate in the study. After obtaining informed consent, participants will be randomized using a validated web-based randomization tool. Patients who are randomized to receive a wipe will receive verbal and printed/visual instructions to take with them for sample collection.
Patients who are asymptomatic, have an indwelling catheter, SPT, stent, nephrostomy tube, perform CIC, are on daily antibiotic prophylaxis, or already on existing antibiotics will be excluded.
The study will be open for approximately 1 year to enroll participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •adult female patients >18 who present to the urology clinic at IRL or 3RC with a symptomatic UTI: symptoms include urgency, frequency, urgency urinary incontinence increased from baseline symptoms, dysuria, fevers, flank pain, suprapubic pain/pressure, low back pain, cloudy urine, malodorous urine
排除标准
- •patients who are asymptomatic, have an indwelling catheter, SPT, stent, nephrostomy tube, perform CIC, are on daily antibiotic prophylaxis, or already on existing antibiotics
研究组 & 干预措施
No Wipe
Patient will not use wipe before collecting mid-stream clean catch culture
Perineal Wipe
Patient will use wipe before collecting mid-stream clean catch culture
干预措施: Perineal Wipe (Other)
结局指标
主要结局
Rate of Contamination
时间窗: 1 year
rate of contamination of midstream clean catch urine samples
次要结局
未报告次要终点
研究者
Joanna A. Orzel
Principal Investigator
University of Iowa