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

09 May 2024
Volume 33 · Issue 9

Abstract

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.

Clean intermittent self-catheterisation (CISC) involves passing a hollow tube (catheter) into the bladder to drain off urine when clinically indicated, with the tube removed immediately. This procedure, also known as intermittent self-catheterisation, was developed by Jack Lapides more than 50 years ago (Lapides et al, 1972; Angermund et al, 2021). Before this development, indwelling urinary catheters were the norm and these brought about numerous complications, especially urinary tract infections (UTIs) (Broom et al, 2022).

While CISC has been recognised as the gold standard (National Institute for Health and Care Excellence (NICE), 2015) for draining a dysfunctional bladder, the devices bring their own risks and complications including UTIs. While several systematic reviews (Rognoni et al, 2017; Shamout et al, 2017), cohort studies (Chartier-Kastler et al, 2022) and guideline summaries (Campeau et al, 2020) have attempted to identify the effectiveness of different types of CISC catheters in reducing catheter-associated urinary infections (CAUTIs), very little good-quality evidence is available apart from a review by Barken and Vaabengaard (2022), which identified that catheters with a hydrophilic coating were more effective in preventing CAUTIs than non-hydrophilic ones.

Intermittent catheters historically have been conventional two-eyelet catheters (CECs) and have not changed in design since conception. However, an innovative design incorporating Micro-hole Zone Technology (MHZT) called Luja has been developed (Figure 1).

Figure 1. Luja intermittent catheter

This article will discuss the benefits of CISC over indwelling catheter use. It will also examine some of their complications and how the new design of the Luja intermittent catheter can overcome these.

Needs and advantages of clean intermittent self-catheterisation

CISC is a common, well-tolerated procedure employed to empty a bladder that is dysfunctional, usually because of neurological or urological voiding issues. The procedure involves passing a catheter into the bladder to drain off urine when clinically indicated, and the catheter is then immediately removed (Lister et al, 2020; Yates, 2023).

CISC may be used in the short term (eg for voiding problems after surgery or giving birth, and in men with enlarged prostate before surgery), or as a long-term bladder management strategy (eg in patients with spinal cord injuries, spina bifida, cauda equina syndrome, multiple sclerosis, diabetes or cerebrovascular accident). It has recognised advantages over indwelling forms of catheterisation (urethral or suprapubic), as it has no retaining balloon (Yates, 2023) and allows periodic filling and emptying of the bladder to mimic a normal bladder function (Leaver, 2024). It is associated with fewer UTIs and encrustation caused by indwelling catheters (Woodward, 2014), improves urinary symptoms, allows for sexual activity, promotes independence and improves quality of life (Woodward, 2014; Balhi et al, 2021; Leaver, 2024). This means that it is often seen as the gold standard for artificial bladder emptying (NICE, 2015).

Complications and risk factors

Data on the prevalence of CISC users are scant, but UK statistics show approximately 50 000 individuals use an intermittent catheter (Wilks et al, 2020). With so many people requiring this intervention, the clinical need for CISC and its advantages over indwelling forms of catheterisation are clear. Nonetheless, complications exist. One of the most frequent is the development of UTIs (Balhi et al, 2021), with incidence rates in those carrying out CISC in the community to be reported as 0.8-3.5 per patient per year (Kennelly et al, 2019). This could potentially mean 70–105 UTIs over a CISC user's lifetime (Kennelly et al, 2019). A recent survey by Vaabengaard et al (2023) of more than 2942 CISC users reported an average of 2.7 UTIs in a year, with 14% of patients experiencing six or more.

The reasons for complications and risk factors with regards to UTIs in CISC users are multifactorial. Kennelly et al (2019) identified them as falling into four domains (Figure 2):

  • The patient's general condition, eg impaired bladder compliance, bowel dysfunction, diabetes, age, sex
  • Local urinary tract conditions, eg bacterial virulence, previous UTIs, botulinum toxin A injections, urodynamic investigations and post-CISC residual urine as a result of bladder shape
  • Routine aspects related to patient adherence, eg voiding frequency, fluid intake, non-hygienic procedure, post-CISC residual urine resulting from incorrect handling and education
  • Factors relating to the intermittent catheters themselves, eg insertion of bacteria via catheter, urethral or bladder trauma from the catheter and post-CISC residual urine because of catheter design.
Figure 2. Urinary tract infection (UTI) risk factor model with its four domains

While the UTI risk factor model encompasses four domains, three of the most significant risks for UTIs will be discussed in this article: poor hygiene, technique or adherence; raised post-CISC residual urine; and bladder trauma.

Impact on users and how nurses can help

Care by professionals for patients who undertake CISC to prevent UTIs include: preventing contamination by educating individuals on hand hygiene and the importance of handwashing (including nails) (Yates, 2023) and advice on washing the genital area before insertion. It also includes assessing each individual to ensure correct product selection, including of their mobility and dexterity and therefore ability to manipulate a catheter, while noting evidence that hydrophilic catheters result in fewer UTIs and less micro trauma than non-coated catheters (Li et al, 2013; Hillery, 2022).

Patients new to CISC may be unaware of the importance of effective bladder drainage and believe that, once urine has stopped flowing, the catheter can be immediately withdrawn (Hillery, 2022). This, however, can leave behind a quantity of urine to stagnate, which is ideal for bacterial growth (Ipe et al, 2016). Incomplete bladder emptying leading to residual urine allows growth of leftover bacteria, which may cause permanent bacteriuria. More serious consequences of UTIs include frequent recurrences, pyelonephritis, urosepsis, renal failure, and high-level antibiotic resistance (Barken and Vaabengaard 2022). Patients should be made aware that the bladder needs time to drain and that they should rotate the catheter on removal (Lister et al, 2020). It is important that they comprehend and adhere to the frequency and regimen recommended when using a CISC (Yates, 2023); failure to do so could result in high volumes of post-CISC residual urine volumes and UTIs.

Introducing intermittent self-catheterisation

As discussed above, there are a number of significant risk factors for UTIs with regards to CISC. The main ones identified by an expert panel and supported by Kennelly et al (2019) are poor hygiene, technique and adherence, high post CISC residual urine; and bladder trauma. When CISC is introduced to patients, it is imperative that these are discussed in depth.

Poor hygiene technique

Undertaking CISC can introduce bacteria into the bladder via the urethra and, if residual urine is present, this can provide a medium in which bacteria can flourish. There is a natural biome in the bladder; some bacteria are known to have a protective effect but, when other bacteria are introduced via CISC and allowed to proliferate, the natural protective population of bacteria is destabilised and this can potentially cause CAUTI (Neugent et al, 2020).

High post-procedure residual urine

Post-CISC residual urine is known to contribute to UTIs and is a concern for most CISC users, with 47% worried about their bladder not being emptied (Islamoska et al, 2022; Averbecket al, 2023; Schrøderet al, 2024).

Vahr Lauridsen et al (2024), in the European Association of Urology Nurses guidance, recommended repositioning the catheter to empty the bladder completely; if not undertaken, residual urine can be left. This can prove difficult for individuals who lack sensation or whose dexterity is poor. The guidance also states that the MHZC can empty the bladder without repositioning which will aid some individuals.

There is now evidence that CEC design has been associated with the urine flow stopping too soon because the mucosa of the bladder is sucked into the eyes, causing a blockage (Tentor, 2022).

Such flow stopping can indicate incorrectly that the bladder is empty. When the catheter is repositioned, 78% of users reported the flow started again, which showed urine had remained in the bladder (Vasudeva and Madersbache, 2014). When the catheter is repositioned, the mucosa is released, which can result in micro trauma to the bladder wall and allow access to bacteria (Willumsen et al, 2023), increasing the risk of UTI.

Bladder trauma

If the bladder mucosa is sucked into the eyes of a CEC, this damages the glycosaminoglycan layer of the bladder – a natural protective layer–thus allowing pathogenic bacteria to multiply and potentially cause a UTI (Vasudeva et al, 2014; Stærk et al 2023).

Introduction to Luja Micro-hole Zone Technology

An innovative catheter, Luja, has been designed with more than 80 micro holes (islets) over a 6 cm long drainage zone at the distal end of the catheter. This is designed to ensure complete bladder emptying in one free flow, meaning that when urine stops flowing the bladder will be completely empty, thus preventing post-CISC residual urine and micro trauma to the bladder, so reducing the potential risk of UTIs (Landauro et al, 2023). Luja's 80 plus islets are much smaller than a conventional two islet catheter, therefore preventing the bladder mucosa from being ‘sucked’ into the islet thus preventing microtrauma to the bladder.

Preclinical studies have shown that MHZT results in significantly lower intraluminal catheter pressure, which in turn resulted in significantly less tissue trauma within the bladder (Schrøder et al, 2023); this potentially decreases the risk of UTIs.

Clinical studies have shown similar results with incomplete voiding volume close to zero for MHZT catheters as opposed to the urine flow stopping before the bladder is empty in 0.96–1.32 of episodes when CEC catheters are used. Users reported feeling there was significantly less of a blocking sensation, it was easier to ensure complete bladder voiding and they were significantly more confident their bladder was empty (Landauro et al, 2023; Thiruchelvam et al, 2024).

Studies were also conducted with regards to cloudy urine containing sediment and particles of various shapes and sizes. Both MHZT and CECs drained cloudy urine and no statistical differences between them were identified (Nielsen et al, 2023). The recommendation is that MHZT catheters should be used with caution in patients presenting with a large amount of mucus or large particles in their urine, even though there was no statistical difference in drainage between CECs and MHZT catheters.

The clinical data show that the MHZT Luja catheters provide better clinical outcomes for patients than CECs (Thiruchelvam et al, 2024). Advantages include bladder drainage in one continuous flow, without the flow stopping early and no repositioning required, the potential to reduce micro trauma and residual post-CISC urine; the MHZT catheters may also improve adherence to initial training instructions. Regarding health economics, they could enable professionals to streamline education on CISC and potentially reduce the need for frequent follow-ups, thereby lessening the demand on healthcare resources.

Case study

James Green (not his real name) was an 81-year-old man. He had experienced malignant neoplasm of the prostate in 2022, which had been treated with transurethral prostatectomy, radiotherapy and hormone replacement. He also has atrial fibrillation and heart failure. He had been taught CISC by the hospital urology team after surgery. In the past year, he had experienced 12 falls, including several while trying to self catheterise.

His GP referred him to the bladder and bowel service because of urinary incontinence, requesting pads.

Presentation, assessment and diagnosis

Mr Green was experiencing nocturia, passing urine with CISC 3-4 times during the night and feeling wet. He was performing CISC approximately eight times every 24 hours. He felt a pinching sensation on insertion and withdrawal of the CISC device and was unwilling to reposition the catheter to ensure optimal draining as he anticipated pain and felt he risked falling; he wanted to get the procedure done quickly.

Recent UTIs had affected his balance and he had experienced accidental bowel leakage. Regarding quality of life, he reported feeling low and anxious because of bladder concerns, disturbed sleep and discomfort during the CISC procedure.

The voiding dysfunction was confirmed by a bladder scan. He was found to have urgency to micturate and an overactive bladder. His fluids were high in stimulants and volumes were low for his body size.

Treatment plan

Mr Green was given lifestyle advice to optimise hydration and reduce stimulants. This included providing information on the effects of caffeine alongside coaching to encourage healthier fluid choices.

He was also advised on dietary choices and defecation dynamics, and encouraged to establish a bowel routine. Hygiene was discussed, including hand hygiene, meatal cleansing and correct handling of the intermittent catheter device.

The Luja catheter was demonstrated, and information on MHZT provided. This focused on complete bladder drainage without the need to reposition the catheter, and the reduced risk of trauma and discomfort. Posture while performing CISC at the toilet was discussed to ensure safety and to minimise the risk of falls.

The patient agreed to a trial of the Luja catheter.

Outcome

Mr Green performed CISC with the Luja catheter four times in 24 hours. He reported sleeping all night with no need to perform CISC during that time. He said there was no discomfort during the procedure nor incontinence of urine.

Mr Green's quality of life improved. He had to perform CISC less often and the process was quicker, and he felt confident that the Luja catheter resulted in complete bladder drainage. Education and lifestyle advice for overactive bladder, voiding dysfunction management, urinary incontinence and accidental bowel leakage were successful. Mr Green felt more confident as there were no nocturia, no urinary incontinence and no falls.

The service wrote to the GP to request the CISC prescription was changed to Luja. Mr Green was discharged from the service after two appointments.

Conclusion

While CISC is the gold standard for emptying a dysfunctional bladder, it comes with its own set of complications including post-CISC urine retention, micro trauma and UTIs.

Some of these are exacerbated by the design of CECs, which has not changed for many years. This new MHZT gives professionals opportunities to explore alternative options for patients undertaking CISC. It has the potential to increase adherence to initial training instructions and reduce major complications. While the cost per unit may be slightly higher than that of traditional CECs, this could be offset by the clear clinical benefits to patients, clinicians and healthcare providers. The benefits of this catheter have already been identified and the EAUN guidance (2024) refer to the catheter and state that the Micro-hole Technology may prevent suction in the bladder and subsequently reduce the risk of microtrauma and residual urine.

KEY POINTS

  • Clean intermittent self-catheterisation is a common procedure carried out by people with bladder dysfunction but has complications, especially urinary tract infections
  • Urinary tract infections have mainly been associated with poor hygiene, technique or adherence, high residual urine after intermittent self-catheterisation and bladder trauma
  • Because of their design, conventional two-eyelet catheters may contribute to the higher rates of urinary tract infection seem in patients undertaking clean intermittent self-catheterisation
  • An innovative intermittent catheter using Micro-hole Zone Technology has been shown to have potential to reduce the risks of urinary tract infection in individuals undertaking clean intermittent self-catheterisation

CPD reflective questions

  • What are the risks and complications that may affect individuals carrying out clean intermittent self-catheterisation? How would you advise patients new to the procedure about these?
  • Reflect on how residual urine and micro trauma influence the risk of developing a urinary tract infection
  • Consider the differences between conventional two-eyelet and Micro-hole Zone Technology catheters and how these affect the likelihood of adverse events