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

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ClinicalTrials.gov Identifier: NCT03424499
Recruitment Status : Completed
First Posted : February 7, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Adrián Gutiérrez González, 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 randomized parallel 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) PVC intermittent catheterization. Evaluations were established at 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 sterile technique.

Condition or disease Intervention/treatment Phase
Neurogenic Bladder Due to Spina Bifida (Disorder) Procedure: Single-use catheter Procedure: Reused catheter Diagnostic Test: Urine culture Not Applicable

Detailed Description:

The investigators performed a randomized 2-arm trial at University Hospital "Dr. José Eleuterio González", a third level hospital in Monterrey, Mexico. The study population were patients with spina bifida treated in University Hospital. Participants and parents were offered optional entrance to the study.

Sample size was calculated considering a total of 165 active patients with spina bifida treated in University Hospital, using a power of 80%, an expected difference of 50% between arms, and alpha level set at 0.05. The sample size calculated was 83 subjects, using methods for correlated binary data and repeated measures.

Subjects were randomized into 2 groups: Group 1 was assigned to use a single-use PVC catheter. Group 2 was assigned to use the standard practice modality, a reused PVC catheter. Both groups were instructed to use sterile water-soluble lubricant in each catheterization. In the reused catheter group, after catheterization, PVC catheter was washed with water and soap, and stored in a container with 0.5% benzalkonium chloride. 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 bladder catheterization technique before the trial. All participants were provided with written informed consent.

Both groups had a follow-up of 8 weeks. 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. At each appointment urine culture results were evaluated, and if symptoms of UTI were present (temperature greater than 38.3 ° C, turbidity or odorous), antibiotic therapy according to antimicrobial susceptibility. Side effects related to bladder catheterization (hematuria, urethral stenosis, false way) were also evaluated. Patients with UTI were treated with antibiotics adjusted to the urine culture and were instructed to continue catheterization.

A clinical record format was used in all programmed appointments recording urine culture results, demographics, pharmacologic therapy, urological comorbidities, and urodynamic characteristics. Personal information related to participants identity was not recorded.

Subjects were randomized into block sizes of 6 using a computer generated list. Blinding process was impossible due to the nature of intervention therapy.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized into 2 parallel groups: Group 1 will be assigned to use a single-use polyvinylchloride (PVC) catheter for Intermittent bladder catheterization for neurogenic bladder. Group 2 will use a reused PVC catheter. Both groups will have a follow-up of 8 weeks. Subjects will be randomized into block sizes of 6 using a computer generated list. Both groups will be instructed to use sterile water-soluble lubricant in each catheterization. In the reused catheter group, PVC catheter is washed with water and soap, and stored in a container with 0.5% benzalkonium chloride. Each catheter is programmed to last a week. Patients and parents are going to be instructed to use clean technique by hand washing with water and soup, and penis/vulva cleansing with antiseptic wipes. Urine cultures will be taken on day 0, 7, 14, 28, 42 and 56, collecting urine samples from a fresh midstream catheter specimen, and evaluation of symptoms related to urinary tract infections.
Masking: Single (Outcomes Assessor)
Masking Description: Blinding process to participants and care providers was impossible due to the nature of intervention therapy. Data were analyzed by an impartial statistician (outcomes assessor), referring to each arm with an encoded name: Group A (sterile single-use catheter) and Group B (Reused catheter).
Primary Purpose: Treatment
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
Actual Study Start Date : August 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


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 Name: 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

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 soup 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
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, PVC catheter was washed with water and soap, and stored in a container with 0.5% benzalkonium chloride. 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 Name: Reused clean 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.




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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03424499


Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
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Principal Investigator: Adrian Gutiérrez-González Universidad Autónoma de Nuevo León

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Adrián Gutiérrez González, Dr. med. Adrián Gutiérrez González, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT03424499     History of Changes
Other Study ID Numbers: UR16-00005
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adrián Gutiérrez González, Hospital Universitario Dr. Jose E. Gonzalez:
neurogenic bladder
intermittent urethral catheterization
Clean intermittent catheterization
Additional relevant MeSH terms:
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Urinary Bladder, Neurogenic
Spinal Dysraphism
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms
Neural Tube Defects
Nervous System Malformations
Congenital Abnormalities
Benzalkonium Compounds
Anti-Infective Agents, Local
Anti-Infective Agents