Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06296901
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-28
Brief Title:
To Wipe or Not To Wipe That Is The Question
Sponsor:
Joanna A Orzel
Organization:
University of Iowa
Study Overview
Official Title:
o Wipe or Not To Wipe That Is The Question
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 printedvisual 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 painpressure 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 N600 even allocation provides 300 patients per group There would be 693 power when testing for a between-group difference at alpha 005
Demographics of the patients will be assessed via summary statistics Comparisons between the demographics of the two groups will be made using Fishers 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
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 printedvisual 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 painpressure 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 N600 even allocation provides 300 patients per group There would be 693 power when testing for a between-group difference at alpha 005
Demographics of the patients will be assessed via summary statistics Comparisons between the demographics of the two groups will be made using Fishers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None