An interventional study of Single-use catheter and Reused catheter in Neurogenic Bladder Due to Spina Bifida (Disorder), sponsored by Hospital Universitario Dr. Jose E. Gonzalez. Completed. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2022-07-06.
Sponsored by Hospital Universitario Dr. Jose E. Gonzalez · Not applicable, Interventional, and Treatment
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.
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.
189 studies on the registry are indexed under Urinary Bladder, Neurogenic; 40 are open to participants now.
This study's enrollment of 113 is above the median of 39 across 125 interventional studies indexed under Urinary Bladder, Neurogenic.
Browse Urinary Bladder, Neurogenic studies →Hospital Universitario Dr. Jose E. Gonzalez is the lead sponsor of 83 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Procedure: Single-use catheter · Diagnostic Test: 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)
Procedure: Reused catheter · Diagnostic Test: 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)
Procedure: Reused catheter · Diagnostic Test: Urine culture
Each urethral catheterization will be done with a new sterile catheter in a period of 8 weeks. Frequency of urethral catheterization will depend of the conditions of each patient (from 3-5 per day). Patients and parents were instructed to use clean technique by hand washing with water and soup, and penis/vulva cleansing with antiseptic wipes. Researchers reinforced the intermittent catheterization technique before the trial.
Also known as: Single-use catheter intermittent urethral catheterization
Each catheter is programmed to last 1 week. Evaluation will last a period of 8 weeks. Frequency of urethral catheterization will depend of the conditions of each patient (from 3-5 per day). after catheterization. Each catheter was programmed to last a week. Patients and parents were instructed to use clean technique by hand washing with water and soup, and penis/vulva cleansing with antiseptic wipes. Researchers reinforced the intermittent catheterization technique before the trial.
Also known as: Reused clean catheter intermittent urethral catheterization
A midstream urine sample will be obtained using sterile catheterization for urine culture performed by health provider. Urine cultures will be done in days 0, 7, 14, 28, 42 and 56.
UTIs
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.
Time frame: Urine cultures were done at day 0, 7, 14, 28, 42, and 56 (8 weeks).
Frequency of bacteriuria and UTI in baseline and follow-up urine cultures.
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).
Time frame: Urine cultures were done at day 0, 7, 14, 28, 42, and 56 (8 weeks).
Comorbidities associated to increased frequency of UTI
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.
Time frame: Day 0, 7, 14, 28, 42 and 56 (8 weeks).
Mean person-urine culture UTI, febrile UTI, non-febrile UTI and bacteriuria
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.
Time frame: Urine cultures were done at day 0, 7, 14, 28, 42, and 56 (8 weeks).
No study locations are listed for this record.
Plan to share: No
Ran from Aug 2016 to primary completion in Aug 2021, 60 months.
Of 47 non-industry interventional studies with no phase under Urinary Bladder, Neurogenic, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's 60 months is above that.
Counting every sponsor, half of 51 studies reached it within 33 months; a quarter within 10 and three quarters within 45.
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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Hospital Universitario Dr. Jose E. Gonzalez