o Wipe or Not To Wipe?: That Is The Question
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Rate of Contamination
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •patients who are asymptomatic, have an indwelling catheter, SPT, stent, nephrostomy tube, perform CIC, are on daily antibiotic prophylaxis, or already on existing antibiotics
Arms & Interventions
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
Intervention: Perineal Wipe (Other)
Outcomes
Primary Outcomes
Rate of Contamination
Time Frame: 1 year
rate of contamination of midstream clean catch urine samples
Secondary Outcomes
No secondary outcomes reported
Investigators
Joanna A. Orzel
Principal Investigator
University of Iowa