Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06296901 |
| Other study ID # |
202310353 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2024 |
| Est. completion date |
October 2025 |
Study information
| Verified date |
February 2024 |
| Source |
University of Iowa |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
The following data will be collected via chart review and entered into a REDCap database:
age, BMI, UTI symptoms (urgency, frequency, urgency urinary incontinence increased from
baseline symptoms, dysuria, fevers, flank pain, suprapubic pain/pressure, low back pain,
cloudy urine, malodorous urine), urinalysis and microscopy data (if ordered), final culture
result including contamination type (multiple organisms, skin flora, urogenital flora, group
B streptococcus, lactobacillus), antibiotic treatment.
Sample size calculations were performed based on an expected 60% contamination rate for the
no wipe group. If an anticipated maximum contamination rate of 50% for the wipe group, that
provides a 10% between-group difference. For an N=600, even allocation provides 300 patients
per group. There would be 69.3% power when testing for a between-group difference at alpha =
0.05.
Demographics of the patients will be assessed via summary statistics. Comparisons between the
demographics of the two groups will be made using Fisher's Exact or chi squared tests for
categorical variables and using T-test or Wilcoxon rank sum tests for continuous variables,
where appropriate. Primary outcomes will also be compared using treatment-stratified summary
statistics, and p-values obtained using the aforementioned statistical tests.
