Neurogenic Bladder Due to Spina Bifida (Disorder)CathetersNCT03424499
Sterile Single-use vs Reused Polyvinylchloride Catheter For Intermittent Catheterization In Neurogenic Bladder
A study testing Single-use catheter, Reused catheter and Urine culture in people with Neurogenic Bladder Due to Spina Bifida (Disorder), run by Hospital Universitario Dr. Jose E. Gonzalez.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Neurogenic Bladder Due to Spina Bifida (Disorder)
- What is being tested?
- Single-use catheter, Reused catheter and Urine culture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Being tested
- Single-use catheter, Reused catheter, Urine culture
- Keywords
- neurogenic bladder, intermittent urethral catheterization, Clean intermittent catheterization
- Medical subject headings
- Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-use catheterProcedure or surgery
Also called Single-use catheter intermittent urethral catheterization
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.
Reused catheterProcedure or surgery
Also called Reused clean 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.
Urine cultureDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-use catheter | Active comparator | 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) Receives: Procedure: Single-use catheter; Diagnostic Test: Urine culture |
| Reused catheter with 0.5% benzalkonium chloride | Experimental | 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) Receives: Procedure: Reused catheter; Diagnostic Test: Urine culture |
| Reused catheter with soap and water | Experimental | 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) Receives: Procedure: Reused catheter; Diagnostic Test: Urine culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Urine cultures were done at day 0, 7, 14, 28, 42, and 56 (8 weeks).
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: Urine cultures were done at day 0, 7, 14, 28, 42, and 56 (8 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study startAug 2016
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Neurogenic Bladder Due to Spina Bifida (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects assigned into 3 parallel groups: Group1 assigned to use a single-use PVC catheter for Intermittent bladder catheterization for neurogenic bladder. Group2 and Group3 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 an electronic 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, stored in a container with 0.5% benzalkonium chloride, Group3 catheter washed with water and soap alone. Each catheter is programmed to last a week. Patients/parents are going to be instructed to use clean technique by hand washing with water and soap, and penis/vulva cleansing with antiseptic wipes. Urine cultures will be taken day 0,7,14,28,42 and 56, collecting urine samples from fresh midstream catheter specimen, and evaluation of symptoms related to urinary tract infections.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrián Gutiérrez González, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- Adrian Gutiérrez-González, Principal investigator, Universidad Autónoma de Nuevo León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424499
- Sponsor's protocol ID
- UR16-00005
- Acronym
- Catheters
- Status last verified
- Jun 2022
- First submitted
- 23 Jan 2018
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Snow-Lisy DC, Yerkes EB, Cheng EY. Update on Urological Management of Spina Bifida from Prenatal Diagnosis to Adulthood. J Urol. 2015 Aug;194(2):288-96. doi: 10.1016/j.juro.2015.03.107. Epub 2015 Apr 1.
PubMed 25839383Oakeshott P, Hunt GM, Poulton A, Reid F. Expectation of life and unexpected death in open spina bifida: a 40-year complete, non-selective, longitudinal cohort study. Dev Med Child Neurol. 2010 Aug;52(8):749-53. doi: 10.1111/j.1469-8749.2009.03543.x. Epub 2009 Dec 9.
PubMed 20015251Lapides J, Diokno AC, Silber SJ, Lowe BS. Clean, intermittent self-catheterization in the treatment of urinary tract disease. J Urol. 1972 Mar;107(3):458-61. doi: 10.1016/s0022-5347(17)61055-3. No abstract available.
PubMed 5010715Bowman RM, McLone DG, Grant JA, Tomita T, Ito JA. Spina bifida outcome: a 25-year prospective. Pediatr Neurosurg. 2001 Mar;34(3):114-20. doi: 10.1159/000056005.
PubMed 11359098Guttmann L, Frankel H. The value of intermittent catheterisation in the early management of traumatic paraplegia and tetraplegia. Paraplegia. 1966 Aug;4(2):63-84. doi: 10.1038/sc.1966.7. No abstract available.
PubMed 5969402Shamout S, Biardeau X, Corcos J, Campeau L. Outcome comparison of different approaches to self-intermittent catheterization in neurogenic patients: a systematic review. Spinal Cord. 2017 Jul;55(7):629-643. doi: 10.1038/sc.2016.192. Epub 2017 Jan 24.
PubMed 28117329Campbell JB, Moore KN, Voaklander DC, Mix LW. Complications associated with clean intermittent catheterization in children with spina bifida. J Urol. 2004 Jun;171(6 Pt 1):2420-2. doi: 10.1097/01.ju.0000125200.13430.8a.
PubMed 15126866Schlager TA, Dilks S, Trudell J, Whittam TS, Hendley JO. Bacteriuria in children with neurogenic bladder treated with intermittent catheterization: natural history. J Pediatr. 1995 Mar;126(3):490-6. doi: 10.1016/s0022-3476(95)70477-9.
PubMed 7869216The prevention and management of urinary tract infections among people with spinal cord injuries. National Institute on Disability and Rehabilitation Research Consensus Statement. January 27-29, 1992. J Am Paraplegia Soc. 1992 Jul;15(3):194-204. doi: 10.1080/01952307.1992.11735873.
PubMed 1500945Sutherland RS, Kogan BA, Baskin LS, Mevorach RA. Clean intermittent catheterization in boys using the LoFric catheter. J Urol. 1996 Dec;156(6):2041-3.
PubMed 8911385Moore KN, Burt J, Voaklander DC. Intermittent catheterization in the rehabilitation setting: a comparison of clean and sterile technique. Clin Rehabil. 2006 Jun;20(6):461-8. doi: 10.1191/0269215506cr975oa.
PubMed 16892928Chaudhry R, Balsara ZR, Madden-Fuentes RJ, Wiener JS, Routh JC, Seed P, Ross SS. Risk Factors Associated With Recurrent Urinary Tract Infection in Neurogenic Bladders Managed by Clean Intermittent Catheterization. Urology. 2017 Apr;102:213-218. doi: 10.1016/j.urology.2016.12.049. Epub 2017 Jan 5.
PubMed 28065810Mukai S, Shigemura K, Nomi M, Sengoku A, Yamamichi F, Fujisawa M, Arakawa S. Retrospective study for risk factors for febrile UTI in spinal cord injury patients with routine concomitant intermittent catheterization in outpatient settings. Spinal Cord. 2016 Jan;54(1):69-72. doi: 10.1038/sc.2015.170. Epub 2015 Oct 13.
PubMed 26458969Dean GE. Are Single Use Catheters Worth the Expense? J Urol. 2015 Jul;194(1):12-3. doi: 10.1016/j.juro.2015.04.071. Epub 2015 Apr 16. No abstract available.
PubMed 25892142Bermingham SL, Hodgkinson S, Wright S, Hayter E, Spinks J, Pellowe C. Intermittent self catheterisation with hydrophilic, gel reservoir, and non-coated catheters: a systematic review and cost effectiveness analysis. BMJ. 2013 Jan 8;346:e8639. doi: 10.1136/bmj.e8639.
PubMed 23303886
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03424499
- Acronym / sponsor ID
- Catheters / UR16-00005
- Keywords
- neurogenic bladder, intermittent urethral catheterization, Clean intermittent catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects assigned into 3 parallel groups: Group1 assigned to use a single-use PVC catheter for Intermittent bladder catheterization for neurogenic bladder. Group2 and Group3 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 an electronic 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, stored in a container with 0.5% benzalkonium chloride, Group3 catheter washed with water and soap alone. Each catheter is programmed to last a week. Patients/parents are going to be instructed to use clean technique by hand washing with water and soap, and penis/vulva cleansing with antiseptic wipes. Urine cultures will be taken day 0,7,14,28,42 and 56, collecting urine samples from fresh midstream catheter specimen, and evaluation of symptoms related to urinary tract infections.
| Arm | Type | Receives |
|---|---|---|
| Single-use catheter | Active comparator | Procedure: Single-use catheter, Diagnostic Test: Urine cultureParticipants 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 | Experimental | Procedure: Reused catheter, Diagnostic Test: Urine cultureParticipants 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 | Experimental | Procedure: Reused catheter, Diagnostic Test: Urine cultureParticipants 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) |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- other causes of neurogenic bladder,
- symptomatic UTI at the time of initial evaluation,
- inconsistent IC,
- indwelling catheter,
- allergy to PVC,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-use catheterAlso: Single-use catheter intermittent urethral catheterizationEach 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. | Procedure or surgery | Single-use catheter |
| Reused catheterAlso: Reused clean catheter intermittent urethral catheterizationEach 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. | Procedure or surgery | Reused catheter with 0.5% benzalkonium chloride, Reused catheter with soap and water |
| Urine cultureA 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. | Diagnostic test | Reused catheter with 0.5% benzalkonium chloride, Reused catheter with soap and water, Single-use catheter |
Primary outcome
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.
3 secondary outcomes
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).
Comorbidities associated to increased frequency of UTI
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Background: PubMed 25839383Snow-Lisy DC, Yerkes EB, Cheng EY. Update on Urological Management of Spina Bifida from Prenatal Diagnosis to Adulthood. J Urol. 2015 Aug;194(2):288-96. doi: 10.1016/j.juro.2015.03.107. Epub 2015 Apr 1.
- Background: PubMed 20015251Oakeshott P, Hunt GM, Poulton A, Reid F. Expectation of life and unexpected death in open spina bifida: a 40-year complete, non-selective, longitudinal cohort study. Dev Med Child Neurol. 2010 Aug;52(8):749-53. doi: 10.1111/j.1469-8749.2009.03543.x. Epub 2009 Dec 9.
- Background: PubMed 5010715Lapides J, Diokno AC, Silber SJ, Lowe BS. Clean, intermittent self-catheterization in the treatment of urinary tract disease. J Urol. 1972 Mar;107(3):458-61. doi: 10.1016/s0022-5347(17)61055-3. No abstract available.
- Background: PubMed 11359098Bowman RM, McLone DG, Grant JA, Tomita T, Ito JA. Spina bifida outcome: a 25-year prospective. Pediatr Neurosurg. 2001 Mar;34(3):114-20. doi: 10.1159/000056005.
- Background: PubMed 5969402Guttmann L, Frankel H. The value of intermittent catheterisation in the early management of traumatic paraplegia and tetraplegia. Paraplegia. 1966 Aug;4(2):63-84. doi: 10.1038/sc.1966.7. No abstract available.
- Background: PubMed 28117329Shamout S, Biardeau X, Corcos J, Campeau L. Outcome comparison of different approaches to self-intermittent catheterization in neurogenic patients: a systematic review. Spinal Cord. 2017 Jul;55(7):629-643. doi: 10.1038/sc.2016.192. Epub 2017 Jan 24.
- Background: PubMed 15126866Campbell JB, Moore KN, Voaklander DC, Mix LW. Complications associated with clean intermittent catheterization in children with spina bifida. J Urol. 2004 Jun;171(6 Pt 1):2420-2. doi: 10.1097/01.ju.0000125200.13430.8a.
- Background: PubMed 7869216Schlager TA, Dilks S, Trudell J, Whittam TS, Hendley JO. Bacteriuria in children with neurogenic bladder treated with intermittent catheterization: natural history. J Pediatr. 1995 Mar;126(3):490-6. doi: 10.1016/s0022-3476(95)70477-9.
- Background: PubMed 1500945The prevention and management of urinary tract infections among people with spinal cord injuries. National Institute on Disability and Rehabilitation Research Consensus Statement. January 27-29, 1992. J Am Paraplegia Soc. 1992 Jul;15(3):194-204. doi: 10.1080/01952307.1992.11735873.
- Background: PubMed 8911385Sutherland RS, Kogan BA, Baskin LS, Mevorach RA. Clean intermittent catheterization in boys using the LoFric catheter. J Urol. 1996 Dec;156(6):2041-3.
- Background: PubMed 16892928Moore KN, Burt J, Voaklander DC. Intermittent catheterization in the rehabilitation setting: a comparison of clean and sterile technique. Clin Rehabil. 2006 Jun;20(6):461-8. doi: 10.1191/0269215506cr975oa.
- Background: PubMed 28065810Chaudhry R, Balsara ZR, Madden-Fuentes RJ, Wiener JS, Routh JC, Seed P, Ross SS. Risk Factors Associated With Recurrent Urinary Tract Infection in Neurogenic Bladders Managed by Clean Intermittent Catheterization. Urology. 2017 Apr;102:213-218. doi: 10.1016/j.urology.2016.12.049. Epub 2017 Jan 5.
- Individual participant dataSharing planned: No
Related trials for Neurogenic Bladder Due to Spina Bifida (Disorder)
Recruiting
Tibial Nerve Stimulation for Pediatric Spina Bifida Neurogenic Bladder
Neurogenic Bladder Due to Spina Bifida
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Gutiérrez-González principal investigator
Universidad Autónoma de Nuevo León
Questions about this trial
What is this clinical trial studying?
A study testing Single-use catheter, Reused catheter and Urine culture in people with Neurogenic Bladder Due to Spina Bifida (Disorder), run by Hospital Universitario Dr. Jose E. Gonzalez.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UTIs (time frame: Urine cultures were done at day 0, 7, 14, 28, 42, and 56 (8 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03424499, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.