Urinary Tract InfectionsNCT06296901
To Wipe or Not To Wipe?: That Is The Question
A study testing Perineal Wipe in people with Urinary Tract Infections, run by Joanna A. Orzel at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Perineal Wipe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients who are asymptomatic, have an indwelling catheter, SPT, stent, nephrostomy tube, perform CIC, are on daily antibiotic prophylaxis, or already on existing antibiotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Urinary Tract Infections
- Being tested
- Perineal Wipe
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal WipeOther
Also called PDI Castile Soap Towelettes
use of perineal wipe
| Study group | Role | What they receive |
|---|---|---|
| Perineal Wipe | Experimental | Patient will use wipe before collecting mid-stream clean catch culture Receives: Other: Perineal Wipe |
| No Wipe | No intervention | Patient will not use wipe before collecting mid-stream clean catch culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Contamination
rate of contamination of midstream clean catch urine samples
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Apr 2024
- Primary completionMay 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joanna A. Orzel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joanna A. Orzel, University of Iowa
- Investigators
- Joanna A Orzel, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296901
- Sponsor's protocol ID
- 202310353
- Status last verified
- May 2025
- First submitted
- 28 Feb 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- o Wipe or Not To Wipe?: That Is The Question
- ClinicalTrials.gov ID
- NCT06296901
- Acronym / sponsor ID
- 202310353
- Conditions
- Urinary Tract Infections
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Joanna A. OrzelUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perineal Wipe | Experimental | Other: Perineal WipePatient will use wipe before collecting mid-stream clean catch culture |
| No Wipe | No intervention | –Patient will not use wipe before collecting mid-stream clean catch culture |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- patients who are asymptomatic, have an indwelling catheter, SPT, stent, nephrostomy tube, perform CIC, are on daily antibiotic prophylaxis, or already on existing antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perineal WipeAlso: PDI Castile Soap Towelettesuse of perineal wipe | Other | Perineal Wipe |
Primary outcome
Rate of Contamination
Time frame: 1 year
rate of contamination of midstream clean catch urine samples
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna A Orzel principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineal Wipe in people with Urinary Tract Infections, run by Joanna A. Orzel at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Contamination (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.