Ignite Creation Date:
2024-05-06 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03424499
Status:
COMPLETED
Last Update Posted:
2022-07-06
First Post:
2018-01-23
Brief Title:
Sterile Single-use vs Reused Polyvinylchloride Catheter For Intermittent Catheterization In Neurogenic Bladder
Sponsor:
Hospital Universitario Dr Jose E Gonzalez
Organization:
Hospital Universitario Dr Jose E Gonzalez
Study Overview
Official Title:
Randomized Clinical Trial Using Sterile Single-use and Reused Polyvinylchloride Catheter For Intermittent Catheterization With Clean Technique In Neurogenic Bladder Due to Spina Bifida
Status:
COMPLETED
Status Verified Date:
2022-06
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:
Catheters
Brief Summary:
The objective of the study is to determine whether single-use polyvinylchloride PVC catheters reduce urinary tract infections UTI compared to reused PVC catheters for patients with neurogenic bladder due to spina bifida that require intermittent catheterization for bladder emptying The investigators conducted a clinical trial with an 8-week follow-up comparing single-use and reused washed with soap and water and stored in a container with benzalkonium chloride or washed with soap and water alone PVC intermittent catheterization Evaluations were established on days 0 7 14 28 42 and 56 Participants reported symptoms and urine culture results collecting urine samples from a fresh midstream catheter specimen using a sterile technique
Detailed Description:
The investigators performed a 3-arm clinical trial at the Dr José Eleuterio González University Hospital a tertiary-care academic hospital in Monterrey Mexico The study population were patients from a charity institution for individuals with SB Asociación de Espina Bífida de Nuevo León ABP who were treated in our hospital Patients and parents were offered optional entrance to the study Inclusion criteria were age 2 years diagnosis of SB self-IC or performed by a trained person 3 months using a reused PVC catheter 1 per week with a clean technique able to read and understand the informed consent Exclusion criteria were other causes of NB symptomatic UTI at the time of initial evaluation defined as a positive urine culture with pyuria and odorous urine flank pain malaise or fever inconsistent IC an indwelling catheter allergy to PVC urethral pathology eg stricture false passage hypospadias and rejection to participate in the trial The use of a prophylactic antibiotic was not an exclusion criterion provided that the participant continued with their usual therapy for the study duration
The sample size was calculated considering a total of 135 active patients with SB treated in our hospital using a power of 80 an expected difference of 50 between arms and an alpha level set at 005 The sample size needed was 75 subjects using methods for correlated binary data and repeated measures Subjects were assigned into 3 groups Group 1 was assigned to use a single-use PVC catheter Groups 2 and 3 were assigned to use the standard practice modality a reused PVC catheter All groups had a follow-up of 8 weeks Subjects were assigned to block sizes of 6 using a computer-generated list A blinding process was impossible due to the nature of the intervention
All groups were instructed to use sterile water-soluble lubricant in each catheterization In the reused catheter groups after catheterization the PVC catheter was washed with water and soap and stored in a container with 05 benzalkonium chloride or washed with water and soap alone Each catheter was programmed to last a week Patients and parents were instructed to use clean technique by hand washing with water and soap and penisvulva cleansing with antiseptic wipes Researchers reinforced the IC technique before the trial All participants provided written informed consent
The primary outcome measure was UTIs A positive urine culture was defined as the growth of 100000 CFU Positive urine cultures were then classified as asymptomatic bacteriuria defined as a positive urine culture with no symptoms and UTI defined as a positive urine culture with cloudy odorous urine flank pain malaise or fever A total of 6 urine samples were performed per participant considering baseline the first urine culture and follow-up the following samples Participants at baseline were classified as asymptomatic bacteriuria or sterile sample considering that UTI was an exclusion criterion on baseline sample Follow-up outcome was classified as sterile negative urine cultures in all follow-up samples asymptomatic bacteriuria at least 1 positive urine culture with no symptoms at any sample and UTI at least 1 positive urine culture with symptoms
The secondary outcomes included person-urine sample UTI febrile UTI non-febrile UTI asymptomatic bacteriuria and antibiotic use for any reason Demographics pharmacologic therapy urological background and urodynamic characteristics were evaluated in order to establish an association with the presence of UTI Urine cultures were programmed at days 0 7 14 28 42 and 56 Researchers collected all urine samples from a fresh midstream catheter specimen using sterile technique
An impartial statistician analyzed the data Categorical variables were expressed in frequencies and percentages Numerical variables were expressed as means and standard deviation Clinical and demographic characteristics were analyzed using the χ2 test for categorical variables and the t-test or Mann-Whitney test in the absence of normal distribution for continuous variables Statistical significance was set at p 005 SPSS software version 200 IBM Corporation Armonk NY was used for all analyses No funding organization had an influence in the study design analysis or conclusions
The sample size was calculated considering a total of 135 active patients with SB treated in our hospital using a power of 80 an expected difference of 50 between arms and an alpha level set at 005 The sample size needed was 75 subjects using methods for correlated binary data and repeated measures Subjects were assigned into 3 groups Group 1 was assigned to use a single-use PVC catheter Groups 2 and 3 were assigned to use the standard practice modality a reused PVC catheter All groups had a follow-up of 8 weeks Subjects were assigned to block sizes of 6 using a computer-generated list A blinding process was impossible due to the nature of the intervention
All groups were instructed to use sterile water-soluble lubricant in each catheterization In the reused catheter groups after catheterization the PVC catheter was washed with water and soap and stored in a container with 05 benzalkonium chloride or washed with water and soap alone Each catheter was programmed to last a week Patients and parents were instructed to use clean technique by hand washing with water and soap and penisvulva cleansing with antiseptic wipes Researchers reinforced the IC technique before the trial All participants provided written informed consent
The primary outcome measure was UTIs A positive urine culture was defined as the growth of 100000 CFU Positive urine cultures were then classified as asymptomatic bacteriuria defined as a positive urine culture with no symptoms and UTI defined as a positive urine culture with cloudy odorous urine flank pain malaise or fever A total of 6 urine samples were performed per participant considering baseline the first urine culture and follow-up the following samples Participants at baseline were classified as asymptomatic bacteriuria or sterile sample considering that UTI was an exclusion criterion on baseline sample Follow-up outcome was classified as sterile negative urine cultures in all follow-up samples asymptomatic bacteriuria at least 1 positive urine culture with no symptoms at any sample and UTI at least 1 positive urine culture with symptoms
The secondary outcomes included person-urine sample UTI febrile UTI non-febrile UTI asymptomatic bacteriuria and antibiotic use for any reason Demographics pharmacologic therapy urological background and urodynamic characteristics were evaluated in order to establish an association with the presence of UTI Urine cultures were programmed at days 0 7 14 28 42 and 56 Researchers collected all urine samples from a fresh midstream catheter specimen using sterile technique
An impartial statistician analyzed the data Categorical variables were expressed in frequencies and percentages Numerical variables were expressed as means and standard deviation Clinical and demographic characteristics were analyzed using the χ2 test for categorical variables and the t-test or Mann-Whitney test in the absence of normal distribution for continuous variables Statistical significance was set at p 005 SPSS software version 200 IBM Corporation Armonk NY was used for all analyses No funding organization had an influence in the study design analysis or conclusions
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