Sterile Single-use vs Reused Polyvinylchloride Catheter For Intermittent Catheterization In Neurogenic Bladder
NCT ID: NCT03424499
Last Updated: 2022-07-06
Study Results
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Basic Information
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COMPLETED
NA
113 participants
INTERVENTIONAL
2016-08-31
2021-08-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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)
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.
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.
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)
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.
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.
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)
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.
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.
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Years
ALL
No
Sponsors
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Hospital Universitario Dr. Jose E. Gonzalez
OTHER
Responsible Party
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Adrián Gutiérrez González
Dr. med. Adrián Gutiérrez González
Principal Investigators
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Adrian Gutiérrez-González
Role: PRINCIPAL_INVESTIGATOR
Universidad Autónoma de Nuevo León
References
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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.
Oakeshott 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.
Lapides 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.
Bowman 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.
Guttmann 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.
Shamout 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.
Campbell 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.
Schlager 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.
The 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.
Sutherland RS, Kogan BA, Baskin LS, Mevorach RA. Clean intermittent catheterization in boys using the LoFric catheter. J Urol. 1996 Dec;156(6):2041-3.
Moore 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.
Chaudhry 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.
Mukai 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.
Dean 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.
Bermingham 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.
Prieto J, Murphy CL, Moore KN, Fader M. Intermittent catheterisation for long-term bladder management. Cochrane Database Syst Rev. 2014 Sep 10;(9):CD006008. doi: 10.1002/14651858.CD006008.pub3.
Pachler J, Frimodt-Moller C. A comparison of prelubricated hydrophilic and non-hydrophilic polyvinyl chloride catheters for urethral catheterization. BJU Int. 1999 May;83(7):767-9. doi: 10.1046/j.1464-410x.1999.00013.x.
Kiddoo D, Sawatzky B, Bascu CD, Dharamsi N, Afshar K, Moore KN. Randomized Crossover Trial of Single Use Hydrophilic Coated vs Multiple Use Polyvinylchloride Catheters for Intermittent Catheterization to Determine Incidence of Urinary Infection. J Urol. 2015 Jul;194(1):174-9. doi: 10.1016/j.juro.2014.12.096. Epub 2015 Jan 10.
Madero-Morales PA, Robles-Torres JI, Vizcarra-Mata G, Guillen-Lozoya AH, Mendoza-Olazaran S, Garza-Gonzalez E, Gutierrez-Gonzalez A. Randomized Clinical Trial Using Sterile Single Use and Reused Polyvinylchloride Catheters for Intermittent Catheterization with a Clean Technique in Spina Bifida Cases: Short-Term Urinary Tract Infection Outcomes. J Urol. 2019 Jul;202(1):153-158. doi: 10.1097/JU.0000000000000244. Epub 2019 Jun 7.
Other Identifiers
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UR16-00005
Identifier Type: -
Identifier Source: org_study_id
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