Product evaluation of the Luja Micro-hole Zone Technology in clean intermittent self-catheterisation.

Clean intermittent self-catheterisation is a common procedure undertaken by people with bladder dysfunction. However, it is not without its complications, the main one being urinary tract infection. The most common causes of urinary tract infections are poor hygiene, technique and adherence, excessive post-void residual urine and bladder trauma. A catheter with new Micro-hole Zone Technology has been developed, which can potentially improve bladder emptying and minimise these complications. A case study is used to illustrate its effects in practice.

Factors associated with symptomatic urinary tract infection in persons with spinal cord lesions who perform clean intermittent catheterization with single-use catheters.

OBJECTIVES: To investigate factors associated with symptomatic urinary tract infection (sUTI) in persons with chronic spinal cord lesion (SCL) who were using single-use catheters for intermittent self-catheterization (ISC). METHODS: Among respondents to an internet survey on the burden of illness on persons with SCL who were considered to be able to perform ISC, 111 persons using single-use catheters were included to examine factors associated with self-reported sUTI by univariate as well as multivariable analysis. RESULTS: The incidence of sUTI was significantly higher in males than in females (56.9% vs. 31.6%, p = .011), persons with stocks of antibiotics than those without it (82.9% vs. 28.6%, p < .011), and persons with more frequent bleeding during catheterization than those with less frequent bleeding (100% vs. 46.5%, p = .036). The incidence did not significantly differ between respective groups when various variables were evaluated by other characteristics of the participants, adherence to ISC procedures, and complications. On multivariable analysis, male gender and stocks of antibiotics were significant independent factors for sUTI. CONCLUSIONS: Male gender and stocks of antibiotics were associated with sUTI in persons with SCL who were performing ISC with single-use catheters.

Perspectives on technology: Single-use catheters - evidence and environmental impact.

OBJECTIVE: To explore the data comparing single- vs multi-use catheters for clean intermittent catheterisation (CIC), consider if the widespread use of single-use catheters is warranted given the cost and environmental impact, and put forth ideas for future consideration. METHODS: A primary literature review was performed in PubMed over the past 50 years. Studies that performed comparative analysis of single- and multi-use catheters were included in our review. All studies that reported on primary data were narratively summarised. RESULTS: A total of 11 studies were identified that reported on primary data comparing single- and multi-use catheters. There was no appreciable evidence suggesting reusable multi-use catheters were inferior to single-use catheters from an infection or usability standpoint. In addition, the environmental and monetary burden of single-use catheters is significant. CONCLUSIONS: The intermittent catheter landscape in the USA has a complex past: defined by policy, shaped by industry, yet characterised by a paucity of data demonstrating superiority of single-use over multi-use catheters. We believe that the aversion to reusable catheters by many patients and healthcare professionals is unwarranted, especially given the cost and environmental impact. Moving forward, better comparative data and more sustainable practices are needed.

The Preferred Catheter Type After Prolapse Surgery: A Survey Study of Surgeons.

OBJECTIVE: The aim of this study was to determine surgeon preference for catheter type in the management of postoperative urinary retention after prolapse surgery, specifically comparing transurethral indwelling catheters (TIC), clean intermittent self-catheterization (CISC), and suprapubic tubes (SPT). METHODS: Electronic surveys were sent to 1182 urogynecologists and urologists through the American Urogynecologic Society and the Canadian Society of Pelvic Medicine. RESULTS: A total of 247 (21%) surveys were completed, where 53% of the respondents ranked TIC as the best catheter option, compared with 42% for CISC and 4% for SPT (P < 0.0001). Most (75%) of the respondents stated they do not offer their patients a choice in catheter selection. Most (43%) of the respondents ranked ease of use for the patient as the most important catheter characteristic. For ease of use for the patient, 71% of the respondents ranked TIC as the best, compared with CISC and SPT. For all other characteristics (pain/discomfort, infection, catheter malfunction, and return of bladder function), CISC was ranked as the best by the majority. CONCLUSIONS: This study showed that surgeons have a significant preference for TIC over CISC and SPT for the management of postoperative urinary retention, and the majority of surgeons do not offer their patients a choice with regard to catheter type.

An effective evidence-based cleaning method for the safe reuse of intermittent urinary catheters: In vitro testing.

AIMS: To determine a safe bactericidal cleaning method that does not damage urethral catheters used for intermittent catheterization. In some countries, single-use catheters are the norm; in others, the reuse of catheters is common depending on health insurance, personal preference, or individual concerns about the environment. However, no recent study of cleaning methods has been published to provide evidence for the safe reuse of catheters. METHODS: Using advanced microbiological methods, a laboratory study of eight cleaning methods was conducted. Sections of uncoated polyvinylchloride (PVC) catheters were exposed to bacterial uropathogens in physiologically correct artificial urine media then tested with a range of heat, chemical, and mechanical cleaning methods. Analysis of culturable and viable but nonculturable (VBNC) bacteria was done and direct microscopy was used. Descriptive statistics were used to compare values. RESULTS: Heat treatments, although effective, resulted in catheter surface breakdown and damage. Ultrasonic cleaning and vinegar showed evidence of VBNC populations indicating the methods were bacteriostatic. Detergent and water wash followed by immersion in a commercially available 0.6% sodium hypochlorite solution and 16.5% sodium chloride (diluted Milton) gave consistent bactericidal results and no visible catheter damage. CONCLUSIONS: Combined mechanical and chemical treatment of a detergent and water wash followed by immersion in diluted Milton (the "Milton Method") provided consistent and effective cleaning of uncoated PVC catheters, showing bactericidal action for all uropathogens tested after repeated exposure. If found safe in clinical testing, this method could increase the reuse of catheters, reduce plastic waste in the environment, reduce cost, and increase patient choice.

Intermittent catheterization with single- or multiple-reuse catheters: clinical study on safety and impact on quality of life.

PURPOSE: Intermittent catheterization (IC) is a proven effective long-term bladder management strategy for individuals who have lower urinary tract dysfunction. This study provides clinical evidence about multiple-reuse versus single-use catheterization techniques and if catheter choice can have an impact on health-related quality of life (HRQoL). METHOD: A prospective, multi-center, clinical trial studied patients who currently practiced catheter reuse, and who agreed to prospectively evaluate single-use hydrophilic-coated (HC) (i.e. LoFric) catheters for 4 weeks. A validated Intermittent Self-Catheterization Questionnaire (ISC-Q) was used to obtain HRQoL. Reused catheters were collected and studied with regard to microbial and debris contamination. RESULTS: The study included 39 patients who had practiced IC for a mean of 10 years, 6 times daily. At inclusion, all patients reused catheters for a mean of 21 days (SD = 48) per catheter. 36 patients completed the prospective test period and the mean ISC-Q score increased from 58.0 (SD = 22.6) to 67.2 (SD = 17.7) when patients switched to the single-use HC catheters (p = 0.0101). At the end of the study, 83% (95% CI [67-94%]) preferred to continue using single-use HC catheters. All collected reused catheters (100%) were contaminated by debris and 74% (95% CI [58-87%]) were contaminated by microorganisms, some with biofilm. CONCLUSION: Single-use HC catheters improved HRQoL and were preferred over catheter reuse among people practicing IC. Catheter multiple-reuse may pose a potential safety concern due to colonization by microorganisms as well as having reduced acceptance compared to single use. TRIAL REGISTRY NUMBER: ClinicalTrials.gov NCT02129738.

An exploration of men's experiences of learning intermittent self-catheterisation with a silicone catheter.

Intermittent self-catheterisation (ISC) is the method of choice for men with lower urinary tract symptoms who need to drain retained urine from the bladder. It is preferred to using an indwelling urinary catheter as it has lower risks of complications and catheter-associated urinary tract infection. Learning ISC can be challenging for men initially but, with the support of knowledgeable nurses experienced in teaching ISC, the technique can be learned, accepted and normalised, improving symptom control and quality of life. This paper discusses the results of a survey exploring men's experiences of learning ISC with the Hydrosil Go™ (C.R. Bard Inc-now part of Becton, Dickinson and Company) silicone catheter and to highlight issues important to men when learning and living with ISC. The survey collected data from four countries: UK, France, Netherlands and Italy. It aims to help nurses who teach ISC and inform them to discuss what matters to men when learning and living with ISC.

Multiuse Catheters for Clean Intermittent Catheterization in Urinary Retention: Is There Evidence of Inferiority?

In Europe, urinary retention is managed with single-use catheters but there is uncertainty regarding their superiority over multiuse catheters.

Pathogen displacement during intermittent catheter insertion: a novel in vitro urethra model.

AIM: To develop a novel in vitro urethra model and use it to determine if insertion of an intermittent urinary catheter (IC) displaces pathogenic bacteria from the urethral meatus along the urethra. METHODS: Displacement of microbial growth after catheter insertion was assessed using a novel in vitro urethra model. The in vitro urethra model utilized chromogenic agar and was inoculated with bacteria at one side of the artificial urethra channel, to act as a contaminated urethral meatus, before an IC was inserted into the channel. Three ICs types were used to validate the in vitro urethra model and methodology. RESULTS: When compared to the bacterial growth control, a significant difference in bacterial growth was found after insertion of the uncoated (P ≤ 0·001) and hydrophilic coated (P ≤ 0·009) catheters; no significant difference when a prototype catheter was inserted into the in vitro urethra model with either bacterial species tested (P ≥ 0·423). CONCLUSION: The results presented support the hypothesis that a single catheter insertion can initiate a catheter-associated urinary tract infection. SIGNIFICANCE AND IMPACT OF THE STUDY: The in vitro urethra model and associated methodology were found to be reliable and reproducible (P ≥ 0·265) providing new research tool for the development and validation of emerging technologies in urological healthcare.

An investigation of the effectiveness against bacteriuria of silver-coated catheters in short-term urinary catheter applications: A randomized controlled study.

AIM: The aim of this study was to investigate the effectiveness of antimicrobial-coated catheters against bacteriuria and urinary tract infection in patients who have urinary catheterization. METHODS: Twenty eight and twenty six people similar in terms of demographic characteristics and primary and underlying diseases were randomly selected from patients undergoing short-time urinary catheterization in the intensive care unit. Silver-coated slicone foley catheters and normal slicone foley catheters were used for uninary catheterization in the first and second group of the patients respectively. Urine specimens were collected from patients at 2-day intervals and assessed in terms of bacteriuria. RESULTS: Bacteriuria was found in 12 (46.2%) of the patients using normal catheters and 13 (46.4%) of those using silver-coated catheters throughout the monitoring period. No significant relationship was determined between use of different catheter types and bacteriuria (p = 0.98). The most common microorganism was identified as E. coli in the normal catheter group while microorganism other than E. coli was identified in the silver-coated catheter group. The prevalence of bacteriuria was statistically significantly higher in patients with a history of hospitalization in the previous 3 months (p = 0.028). CONCLUSION: The use of silver-coated silicone catheters was not shown to have a protective effect against bacteriuria in this study. Further well-designed studies with larger case numbers are now needed to confirm whether history of hospitalization, which emerged as a statistically significant factor in this study, increases the prevalence of catheter-related bacteriuria.

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.

PURPOSE: Urinary tract infections are common and severe complications in patients with spina bifida. Management includes intermittent bladder catheterization with single use or reused sterile catheters. There is insufficient evidence to set a standard among the different techniques. We determined whether single use polyvinylchloride catheters would reduce urinary tract infections compared to reused polyvinylchloride catheters in patients with neurogenic bladder due to spina bifida. MATERIALS AND METHODS: We performed a 2-arm randomized parallel clinical trial from 2015 to 2016 with an 8-week followup at our center in patients with neurogenic bladder caused by spina bifida. Patients were divided into single use and reused polyvinylchloride catheter groups. Evaluations were done on days 0, 7, 14, 28, 42 and 56. Participants reported symptoms and urine cultures were obtained. The primary outcome was urinary tract infection frequency, defined as positive urine culture plus fever, flank pain, malaise, or cloudy or odorous urine. Study eligibility criteria were age 2 years or greater, spina bifida diagnosis with regular clean intermittent bladder catheterization and no urinary tract infection at initial evaluation. RESULTS: The calculated sample size was 75. Of the patients 135 were screened, 83 were randomized and 75 completed followup. Mean age was 12.7 years (range 2-56) and there were 29 males and 46 females. No statistical difference was found between the single use vs reused catheter groups in the frequency of asymptomatic bacteriuria (32.4% vs 23.7%, p = 0.398) or urinary tract infections (35.2% vs 36.8%, p = 0.877). CONCLUSIONS: Single use polyvinylchloride catheters for intermittent bladder catheterization did not decrease the incidence of urinary tract infections in our patients with neurogenic bladder compared to reused polyvinylchloride catheters. These results are consistent with the 2014 Cochrane Review.

The cost of a catheter: An environmental perspective on single use clean intermittent catheterization.

METHODS: We estimated the prevalence of CIC use in the United States using a neurogenic population, consisting of persons with multiple sclerosis, spina bifida, and spinal cord injury. We measured catheter samples to obtain the amount of waste per catheter. RESULTS: At least 300 800 persons in the United States perform CIC for neurogenic bladder management. Assuming five catheterization events per day, the amount of waste generated by single-use CIC is between 26 500 to 235 400 pounds or 22 600 to 564 000 liters per day, depending on catheter model. CONCLUSIONS: Single-use CIC may generate up to 85 million pounds or 206 million liters of waste annually, equivalent to more than 26 000 cars or 80 Olympic-sized swimming pools. Laid end-to-end, there is enough catheter length circumscribe the world more than 5.5 times. The most common materials used in catheter construction have little to no degradation once in a landfill. Given the unproven clinical benefit of single-use catheterization, the environmental impact and alternatives should be considered.

Selecting an intermittent self-catheter: key considerations.

This article explores the factors that must be considered when assessing patients for intermittent self-catherisation (ISC). It discusses the various types of intermittent catheters and their properties. Key considerations for the health professional when making product recommendations are covered and emphasis is placed on teaching patients the ISC technique. The article also highlights what patients value in terms of product choice and the importance of ongoing support. It concludes by introducing the GentleCath Glide, a new product that incorporates FeelClean™ technology, which leaves less residue on the hands and clothes.

Flow characteristics of urethral catheters of the same caliber vary between manufacturers.

BACKGROUND: Clean intermittent catheterization (CIC) is frequently prescribed for bladder dysfunction, either per urethra or via a continent catheterizable channel. Small catheters may be required for infants or continent channels. Success with CIC is highly dependent upon patient and family compliance. The urinary flow rate through the catheter is an important factor, which can decrease CIC time and improve quality of life. There is little objective information regarding flow rate through urinary catheters to guide catheter recommendation or prescription. Clinically, we noted that there was a difference in flow among catheter brands, and we questioned if catheters of the same-labeled diameter exhibit the same flow characteristics, which could have implications for catheter selection. METHODS: Twenty-one commercially available male pediatric urinary catheters from nine brands were tested (11 straight tip, 10 coude tip). Nine of the 21 tested catheters had a hydrophilic coating. All tested catheters shared a 10F outer diameter. For each, microscopic imaging and a precision caliper were used to measure the inner diameter and tip inlet area. A hydraulic system modified from ASTM standard testing specifications was used to simulate bladder catheterization. Measurement of each catheter was repeated five times using three different static hydraulic pressures (20, 40 and 50 cmH2O). Catheter flow rate and structural measurements were identified and the fastest and slowest of the catheters are presented in the table. The variable flow rates between brands were due to the differences in catheter structural characteristics such as the inner diameter (ID) and the tip inlet area to inner lumen area ratio (AR). The maximum variation of flow rate of all tested 10F catheters was 48%, ID varied up to 22%, from 1.71 to 2.11 mm or 5.13-6.33F. AR varied up to 166%. The table delineates the fastest and slowest rates at three measured pressures. The outer diameter labeled 10F on packaging was true to size. CONCLUSIONS: Based on packaging information, providers, and patients are unable to predict urinary flow through a catheter and thus use information regarding flow rate to guide catheter selection. This information cannot be calculated based on ideal flow calculations and could be listed on packaging to assist physicians and families in selecting the optimal urinary catheter for CIC.

New device for intermittent emptying of the bladder in female children and adolescents: A pilot study.

INTRODUCTION: Urinary incontinence (UI) is a challenging problem for the urological community. Clean intermittent catheterization (CIC) is the most commonly used method to restore bladder emptying to the state close to the physiological condition. This procedure can cause negative aspects such as pain and possible urethral injury. In addition, there is a negative impact on self-image and decline in quality of patient's life. The aim of the present study was to evaluate the safety and efficacy of a new intraurethral self-retaining device (ISRD), in female children and adolescents, as an attractive alternative to CIC. MATERIALS AND METHODS: A prospective clinical pilot study was performed, in a single-institution, including female children and adolescent patients with urinary incontinence secondary to myelomeningocele who were already in an intermittent bladder catheterization program. Assessments included the use of a visual analogue scale in diagnosis of UI, reported adverse events, and the King's Health Questionnaire (KHQ) to evaluate quality of life, which was answered by patients and the caregivers of younger patients before and 6 months after enrolment. DISCUSSION: The device was efficient and well tolerated by most patients (84%). The ISRD significantly improved quality of life in children and adolescents (p<0.0001 for both) (Table). The safe insertion and removal of the ISRD can be considered an advantage compared with CIC as eventual urethral trauma is significantly minimized. It was found that one of the main advantages of the ISRD is the possibility of management as an outpatient procedure both for initial insertion and replacement. The autonomy of patients to perform the bladder emptying process by themselves indicates the importance of this study, especially for school life and social interaction. ISRD use showed a tendency to improve the QoL. CONCLUSIONS: This new bladder-draining device (ISRD) was effective and secure in terms of insertion technique, and improved QoL of patients with urinary retention and incontinence, according to domains evaluated in the KHQ.

Intermittent catheterisation with hydrophilic and non-hydrophilic urinary catheters: systematic literature review and meta-analyses.

BACKGROUND: Intermittent catheterisation is the method of choice for the management of bladder dysfunctions. Different urinary catheters are available, but there is conflicting evidence on which type of catheter is best. The present study provides an objective evaluation of the clinical effectiveness of different subsets of urinary catheters. METHODS: A systematic literature review was performed for published RCTs regarding hydrophilic coated and PVC (standard) catheters for intermittent catheterisation. Separate meta-analyses were conducted to combine data on frequencies of urinary tract infections (UTIs) and haematuria. Two separate analyses were performed, including or excluding reused standard catheters. RESULTS: Seven studies were eligible for inclusion in the review. The meta-analyses exploring UTI frequencies showed a lower risk ratio associated with hydrophilic catheters in comparison to standard ones (RR = 0.84; 95% CI, 0.75-0.94; p = 0.003). Results for the "reuse" scenario were consistent with the ones related to "single-use" scenario in terms of frequency of UTIs. The meta-analyses exploring haematuria were not able to demonstrate any statistically significant difference between hydrophilic catheters in comparison to standard ones. CONCLUSIONS: The findings confirm previously reported benefits of hydrophilic catheters but a broader evaluation that takes into account also patient preferences, compliance of therapy, quality of life and costs would be needed to assess the economic sustainability of these advanced devices.