Clinical trial NCT06296901: To Wipe or Not To Wipe?: That Is The Question
Official title: o Wipe or Not To Wipe?: That Is The Question
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Urinary Tract Infections
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Contamination
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Joanna A Orzel
role: PRINCIPAL_INVESTIGATOR
References: