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

NCT03424499 | Completed DMC

• 1 other identifier: UR16-00005
• Study Type: interventional
• Target: 113
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Neurogenic Bladder Due to Spina Bifida (Disorder)

Keywords

neurogenic bladder; intermittent urethral catheterization; Clean intermittent catheterization

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Urine cultures were done at day 0, 7, 14, 28, 42, and 56 (8 weeks).

• Comorbidities associated to increased frequency of UTI

  Day 0, 7, 14, 28, 42 and 56 (8 weeks).

• Mean person-urine culture UTI, febrile UTI, non-febrile UTI and bacteriuria

  Urine cultures were done at day 0, 7, 14, 28, 42, and 56 (8 weeks).

Study Arms (3)

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)

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)

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)

Procedure: Reused catheter; Diagnostic Test: Urine culture

Interventions

Single-use catheter PROCEDURE

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

Single-use catheter

Reused catheter PROCEDURE

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

Reused catheter with 0.5% benzalkonium chloride; Reused catheter with soap and water

Urine culture DIAGNOSTIC_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.

Reused catheter with 0.5% benzalkonium chloride; Reused catheter with soap and water; Single-use catheter

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Related Publications (19)

• 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.

  PMID: 25839383 BACKGROUND

• 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.

  PMID: 20015251 BACKGROUND

• 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.

  PMID: 5010715 BACKGROUND

• 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.

  PMID: 11359098 BACKGROUND

• 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.

  PMID: 5969402 BACKGROUND

• 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.

  PMID: 28117329 BACKGROUND

• 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.

  PMID: 15126866 BACKGROUND

• 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.

  PMID: 7869216 BACKGROUND

• 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.

  PMID: 1500945 BACKGROUND

• 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.

  PMID: 8911385 BACKGROUND

• 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.

  PMID: 16892928 BACKGROUND

• 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.

  PMID: 28065810 BACKGROUND

• 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.

  PMID: 26458969 BACKGROUND

• 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.

  PMID: 25892142 BACKGROUND

• 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.

  PMID: 23303886 RESULT

• 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.

  PMID: 25208303 RESULT

• 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.

  PMID: 10368193 RESULT

• 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.

  PMID: 25584995 RESULT

• 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.

  PMID: 30916625 RESULT

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Adrian Gutiérrez-González

  Universidad Autónoma de Nuevo León

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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) Group B (Reused catheter with benzalkonium chloride solution) and Group C (Reused catheter)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Adrián Gutiérrez González

Model Details: 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.

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 7, 2018
• Study Start: August 1, 2016
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: July 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share