To Wipe or Not To Wipe?: That Is The Question

o Wipe or Not To Wipe?: That Is The Question

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Other: Perineal Wipe

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.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Perineal Wipe; Patient will use wipe before collecting mid-stream clean catch culture	Other: Perineal Wipe; use of perineal wipe; Other Names: PDI Castile Soap Towelettes
No Intervention: No Wipe; Patient will not use wipe before collecting mid-stream clean catch culture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Contamination	rate of contamination of midstream clean catch urine samples	1 year

Collaborators and Investigators

• Sponsor: Joanna A. Orzel
• Investigators: Principal Investigator: Joanna A Orzel, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 18, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Urinary Tract Infections
• Other Study ID Numbers: 202310353

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No