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

June 30, 2022 updated by: Adrián Gutiérrez González, Hospital Universitario Dr. Jose E. Gonzalez

Randomized Clinical Trial Using Sterile Single-use and Reused Polyvinylchloride Catheter For Intermittent Catheterization With Clean Technique In Neurogenic Bladder Due to Spina Bifida

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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)
Procedure: Single-use catheter
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.
Other Names:
  • Single-use catheter intermittent urethral catheterization
Diagnostic test: Urine culture
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.
Experimental: Reused catheter with 0.5% benzalkonium chloride

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)
Diagnostic test: Urine culture
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.
Procedure: Reused catheter
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.
Other Names:
  • Reused clean catheter intermittent urethral catheterization
Experimental: Reused catheter with soap and water

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)
Diagnostic test: Urine culture
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.
Procedure: Reused catheter
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.
Other Names:
  • Reused clean catheter intermittent urethral catheterization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UTIs
Time Frame: 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.
Urine cultures were done at day 0, 7, 14, 28, 42, and 56 (8 weeks).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of bacteriuria and UTI in baseline and follow-up urine cultures.
Time Frame: 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).
Urine cultures were done at day 0, 7, 14, 28, 42, and 56 (8 weeks).
Comorbidities associated to increased frequency of UTI
Time Frame: 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.
Day 0, 7, 14, 28, 42 and 56 (8 weeks).
Mean person-urine culture 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).
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.
Urine cultures were done at day 0, 7, 14, 28, 42, and 56 (8 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Investigators

  • Principal Investigator: Adrian Gutiérrez-González, Universidad Autonoma de Nuevo Leon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

January 23, 2018

First Submitted That Met QC Criteria

January 31, 2018

First Posted (Actual)

February 7, 2018

Study Record Updates

Last Update Posted (Actual)

July 6, 2022

Last Update Submitted That Met QC Criteria

June 30, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UR16-00005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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