Sterile Single-use vs Reused Polyvinylchloride Catheter For Intermittent Catheterization In Neurogenic Bladder

Not Applicable

Completed

• Conditions: Neurogenic Bladder Due to Spina Bifida (Disorder)
• Interventions: Procedure: Single-use catheter; Procedure: Reused catheter; Diagnostic Test: Urine culture

• Registration Number: NCT03424499
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

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 A.B.P.) 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 0.05. 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 0.5% 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 penis/vulva 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 \>100,000 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 \<0.05. SPSS® software version 20.0 (IBM Corporation, Armonk, NY) was used for all analyses. No funding organization had an influence in the study design, analysis or conclusions.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-01-31
• Study First Posted: 2018-02-07
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

• age ≥ 2 years,
• diagnosis of spina bifida,
• had self-IC or performed by a trained person ≥ 3 months using reused PVC catheter (1 per week) with clean technique,
• able to read and understand informed consent

Exclusion Criteria

• other causes of neurogenic bladder,
• symptomatic UTI at the time of initial evaluation,
• inconsistent IC,
• indwelling catheter,
• allergy to PVC,
• urethral pathology (ie stricture, false passage, hypospadias)
• rejection to participate in trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-use catheter	Urine culture	Participants will use a sterile single-use catheter of polyvinyl chloride (PVC) for intermittent urethral catheterization. Intermittent Bladder Catheterization will be done using clean technique, each PVC catheter will be sterile and used only once for each catheterization. A Urine culture will be performed at day 0, 7, 14, 28, 49 and 56 (a total of 8 cultures)
Single-use catheter	Single-use catheter	Participants will use a sterile single-use catheter of polyvinyl chloride (PVC) for intermittent urethral catheterization. Intermittent Bladder Catheterization will be done using clean technique, each PVC catheter will be sterile and used only once for each catheterization. A Urine culture will be performed at day 0, 7, 14, 28, 49 and 56 (a total of 8 cultures)
Reused catheter with 0.5% benzalkonium chloride	Reused catheter	Participants will use a clean reused catheter of polyvinyl chloride for intermittent urethral catheterization. Intermittent Bladder Catheterization will be done using clean technique. The PVC catheter will be used for 1 week, cleaning the catheter with water and soap after each catheterization and stored in a container with 0.5% benzalkonium chloride. A Urine culture will be performed at day 0, 7, 14, 28, 49 and 56 (a total of 8 cultures)
Reused catheter with soap and water	Reused catheter	Participants will use a clean reused catheter of polyvinyl chloride for intermittent urethral catheterization. Intermittent Bladder Catheterization will be done using clean technique. The PVC catheter will be used for 1 week, cleaning the catheter with water and soap after each catheterization. A Urine culture will be performed at day 0, 7, 14, 28, 49 and 56 (a total of 8 cultures)
Reused catheter with 0.5% benzalkonium chloride	Urine culture	Participants will use a clean reused catheter of polyvinyl chloride for intermittent urethral catheterization. Intermittent Bladder Catheterization will be done using clean technique. The PVC catheter will be used for 1 week, cleaning the catheter with water and soap after each catheterization and stored in a container with 0.5% benzalkonium chloride. A Urine culture will be performed at day 0, 7, 14, 28, 49 and 56 (a total of 8 cultures)
Reused catheter with soap and water	Urine culture	Participants will use a clean reused catheter of polyvinyl chloride for intermittent urethral catheterization. Intermittent Bladder Catheterization will be done using clean technique. The PVC catheter will be used for 1 week, cleaning the catheter with water and soap after each catheterization. A Urine culture will be performed at day 0, 7, 14, 28, 49 and 56 (a total of 8 cultures)

Primary Outcome Measures

Name	Time	Method
UTIs	Urine cultures were done at day 0, 7, 14, 28, 42, and 56 (8 weeks).	A positive urine culture is defined as a growth \>100,000 CFU of organisms. Positive urine cultures were classified as bacteriuria, defined as a positive urine culture with no symptoms, and UTI, defined as a positive urine culture with cloudy, odorous, flank pain, malaise or fever. A total of 6 urine samples were performed per participant. Outcomes will be measured by Mean and Standard Deviation for UTI, Febrile UTI, Non-febrile UTI and Bacteriuria.

Secondary Outcome Measures

Name	Time	Method
Comorbidities associated to increased frequency of UTI	Day 0, 7, 14, 28, 42 and 56 (8 weeks).	Demographic characteristics: gender (frequency and percentage), age in years (mean and standard deviation), and Body Mass Index (weight in kilograms and height in meters will be combined to report BMI in kg/m\^2); Pharmacologic therapy: The use of antimuscarinic treatment (Frequency and percentage) and antibiotic prophylaxis (Frequency and percentage).; Urological comorbidities: Bladder diverticula, Vesicoureteral reflux and hydronephrosis (Frequencies and percentages).; Urodynamic characteristics: hypertonic bladder, overactive detrusor, areflexic bladder, detrusor-sphincter dyssynergy, and filling sensation (Frequencies and percentages).; This data were evaluated in order to stablish association with the presence of UTI. Clinical and demographic characteristics were analyzed using χ2 test for categorical variables, and T-test (or Mann-Whitney test in the absence of normal distribution) for continuous variables.
Mean person-urine culture UTI, febrile UTI, non-febrile UTI and bacteriuria	Urine cultures were done at day 0, 7, 14, 28, 42, and 56 (8 weeks).	A positive urine culture is defined as a growth \>100,000 CFU of organisms. Positive urine cultures were classified as bacteriuria, defined as a positive urine culture with no symptoms, and UTI, defined as a positive urine culture with cloudy, odorous, flank pain, malaise or fever. A total of 6 urine samples were performed per participant. Outcomes will be measured by Mean and Standard Deviation for UTI, Febrile UTI, Non-febrile UTI and Bacteriuria.
Frequency of bacteriuria and UTI in baseline and follow-up urine cultures.	Urine cultures were done at day 0, 7, 14, 28, 42, and 56 (8 weeks).	Baseline was considered the first urine culture (day 0), and follow-up the following samples (from day 7 to 56). Participants on baseline were classified as 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), bacteriuria (at least 1 positive urine culture with no UTI at any sample), and UTI (at least 1 positive urine culture with symptoms).