An estimated 14 million people in the UK live with bladder problems, and bothersome lower urinary tract symptoms (LUTS) can affect up to 30% of men aged >65 years (National Institute of Health and Care Excellence (NICE) (2015). Worldwide, 100 million men are affected by incontinence every year (Irwin et al, 2011).
Urinary incontinence is the spontaneous, unintentional loss of urine (Haylen et al, 2010). Men with incontinence often present with both storage and voiding symptoms.
Types of incontinence include urinary urge incontinence (involuntary leakage of urine combined with a compelling urge to void), stress urinary incontinence (involuntary leakage of urine connected to specific activities such as laughing, sneezing and jumping) and mixed urinary incontinence, which is leakage of urine with a combination of both urge and stress elements (Tran and Puckett, 2023).
Incontinence can also result from urinary retention caused by bladder outlet obstruction and/or atonic bladder; in this case, it is known as overflow incontinence and is characterised by the involuntarily leakage of small amounts of urine. This type of incontinence often occurs in men with benign prostate enlargement (Tran and Puckett, 2023).
Incontinence is more common globally in woman than men with the prevalence in men being around half that in women. It is seen in 11–34% of aging men (Buckley et al, 2010). The higher rate in women is typically tied to issues arising in pregnancy, childbirth or at menopause (Li et al, 2023).
A recent study by Olagundoye et al (2023) found the top risk factors in older men were increasing and advanced age, benign prostatic hyperplasia, diabetes, detrusor overactivity, limitation in physical function or activities of daily living, disability, being overweight or obese, dementia and Parkinson's disease.
Different methods can be used to treat incontinence. The key to management of these patients is taking a detailed history and carrying out a physical examination to identify any reversible causes (Mangir and Chapple, 2020). An accurate diagnosis is of utmost importance. If the incontinence is caused by voiding dysfunction and there is a large post-void residual volume of urine, then clean intermittent self-catheterisation (CISC) is accepted as the evidence-based gold standard for management/bladder drainage (New, 2020; Yates, 2023; Nazarko, 2024). This can be employed as either a temporary measure while awaiting surgery or a permanently when surgery is not an option.
Clean intermittent self-catheterisation
Clean intermittent self-catheterisation (CISC) has long been considered the gold standard for bladder drainage (Nazarko, 2024). Royal College of Nursing (RCN) (2021) guidance on catheter care reinforces NICE (2015) clinical guidelines on management of lower urinary tract symptoms in men, where CISC is identified as the gold standard for urine drainage. RCN (2021) recognise it as preferable to indwelling urethral or suprapubic catheter in patients with dysfunction related to bladder emptying. CISC involves the patient inserting the catheter into the bladder via the urethra or stoma to drain the bladder then remove it immediately after. It can be carried out at home.
CISC has proven advantages over indwelling or suprapubic catheterisation. The two other methods are associated with a range of complications and a higher risks of urinary tract infections (UTIs), so CISC should be used rather than these when possible (NICE, 2015; European Association of Urology (EAU), 2024). CISCs have a lower risk of UTIs than indwelling catheters whether suprapubic or urethral (Tenke et al, 2008; Hooton et al, 2009). It is also associated with a lower risk of bladder stones than indwelling catheters (Hunter et al, 2013; Bartel et al, 2014). Other advantages as well as fewer UTIs include greater patient autonomy, fewer obstacles to sexual intimacy and a better quality of life (Balhi et al, 2021).
In a study of patient experience, all users reported that CISC provided important social, emotional, medical and safety benefits (Health Quality Ontario, 2019).
NICE guidelines (2015) recommend offering CISC before indwelling urethral or suprapubic catheterisation to men with voiding LUTS that cannot be corrected by less invasive measures, and self- or carer-administered intermittent urethral catheterisation before indwelling catheterisation for men with chronic urinary retention.
Complications
As with any medical intervention, complications can occur with CISC. These include false passages, urethral strictures and UTIs, with UTIs being the most common (Bahli et al, 2021). Vaabengaard et al (2023) found in a survey of 2942 patients that 14% of them experienced six or more UTIs per year with an average incidence of 2.7 per year. UTIs can cause physical and psychological complications, which can have a significant impact on patients' quality of life and more serious consequences can arise such as recurrent infections, anti-microbial resistance, urosepsis, pyelonephritis and renal failure (Yates and Weston, 2024). A majority (84%) of patients worry about getting a UTI when self-catheterising and 47% are concerned they have not emptied their bladder completely (Islamoska et al, 2022; Vaabengaard et al, 2023)
UTIs in CISC users have three main risk factors: poor hygiene technique; post-procedure residual urine; and bladder trauma (Kennelly et al, 2019; Yates and Weston; 2024). Each of these issues should be addressed by the health professional responsible for teaching the patient. Patients should be educated on the importance of hygiene, specifically handwashing, and given advice on washing the genital region before insertion. Good manual dexterity and observation of technique is important to ensure maximum bladder drainage.
The health professional should also be able to assist with evidence-based product selection ensuring informed choice and in particular, knowing that hydrophilic catheters cause less micro-trauma and result in fewer UTIs that non-coated catheters; hydrophilic catheters have long been used to prevent UTIs, having been launched in the 1980s (Li et al, 2013; Hillery, 2022).
A new solution: Luja
A recently introduced technology innovation to the catheter market is the Luja. It was first made available in Denmark and Finland in February 2023 then in other countries including the UK over the following 12 months.
This catheter is the first of its kind. This innovation compliments the UN General Assembly UK 2024 commitment to antimicrobial resistance, in particular two of the four themes: reducing the need for, and unintentional exposure to, antimicrobials and investing in innovation, supply and access (World Health Organization, 2024). It aims to address the risk factors for UTIs including post-procedure residual urine and micro-trauma. Instead of 2-3 eyelets, it uses Micro-hole Zone Technology, with more than 80 micro-holes over a 6 cm long area. Preclinical studies have shown that Micro-hole Zone Technology results in notably lower intraluminal catheter pressure, which in turn significantly lessens tissue trauma within the bladder (Schrøder et al, 2024). Yates and Weston (2024) noted that this potentially decreases the risk of urinary infections.
This has been proven in a recent randomised, controlled crossover study where significantly reduced mucosal suction (which can stop the flow of urine) and significantly less residual urine were recorded with the use of Luja in comparison to conventional eyelet catheters (Landauro et al, 2023; Schrøder et al, 2024). Flow stops can falsely reassure the patient that their bladder is empty, leading to prompt removal of the catheter which could potentially result in residual urine.
If a patient has to reposition the catheter to access all the urine because the bladder mucosa has been sucked into the eyelets and stops the flow, this can lead to micro-trauma, in turn leaving the patient more likely to develop a urinary infection (Vasudeva and Madersbacher, 2014; Kennelly et al, 2019). Patients using both hydrophilic and non-hydrophilic catheters can experience haematuria or urethral bleeding (Rognoni and Tarricone, 2017).
Landauro et al (2023) found in three similar randomised controlled crossover studies evaluating the Luja in comparison to conventional two-eyelet catheters that the Luja left a significantly lower mean residual volume at the first flow stop (average differences were 49 ml in men and 32 ml in women). They also found fewer flow stops on average and that the likelihood of haematuria after catheterisation was 5.84 times higher in the group using the conventional two-eyelet catheter. Thiruchelvam et al (2024) noted that the Luja MHZT catheters provided better clinical outcomes for patients then conventional two-eyelet catheters.
Luja enables one single free flow of urine with no need to adjust the catheter when the flow stops, ensuring complete bladder emptying thus reducing the risk of UTIs. It also has been shown to prevent micro-trauma as the micro-holes are much smaller than conventional catheter eyelets; this prevents suction of the bladder mucosa and therefore blockage of the eyelets that can be seen with conventional catheters.
Luja has a dry protective sleeve which supports the no-touch routine and can help those with dexterity issues to have a better grip or patients who need carer support with CIC.
Product evaluation
Bitkina et al (2020) noted that medical devices need to be improved regarding safety and reliability and it is vital to consider the user experience of both patients and practitioners at all stages of developing and designing these. Real-world evaluations can complement or make sense of data obtained in randomised controlled trials; they provide important information and are better able to assess safety and effectiveness as they are performed in clinical areas of practice (Blonde et al, 2018).
With this in mind, a product evaluation was conducted in the UK from 15 September until 30 November. The target groups were both the health professionals training patients on CISC and men aged >18 years carrying out CISC. A total of 40 practitioners and 263 patients were included.
Health professional results
The health professionals included in the evaluation worked with many different patient types with the most common conditions being prostate problems, bladder cancer and post-surgical complications. They had a mix of less experienced (<3 years) and more experienced (>4 years) nurses with equal percentages (35%) in the 1-3 years and >10 years bracket.
On the whole, the practitioners found it easy to train their patients, with 65% saying this was very easy. Nearly all (97%) nurses would recommend Luja, with equal proportions (38%) recommending the device to all their patients and to the majority of their patients.
Case study
Martin Green (not his real name), aged 62 years, is awaiting prostate surgery. He was taught CISC for bladder drainage by the specialist nurse in a LUTS assessment clinic.
He was presented with a selection of intermittent catheters and the benefits of each one was explained and a demonstration given. Mr Green selected Luja and one other type of catheter to try at home to see which he might find easier to use. He remarked at the time that the nurse's advice regarding repositioning of catheters worried him as this would be an additional step he may forget to do. The non-Luja catheter required repositioning. The nurse, who provided feedback regarding teaching, said it was easier to teach patients about the Luja than other catheters. The Luja was also simpler for patients to use as they did not to have to remember to reposition the catheter.
The product evaluation reported that 68% were new to CISC. As Martin was new to CISC, his adherence to technique and the regimen were key to him incorporating the procedure into his daily life. The nurse felt that anything that might help the patient commit to his treatment plan with as few issues as possible would be beneficial.
User results
Of the 263 men included in the evaluation, 56% were aged >70 years of age and 38% were between aged 50-69 years in keeping with the global prevalence noted in the introduction.
Hand dexterity
Most (89%) of the patients had normal hand dexterity, 7% had reduced hand dexterity and 3% had greatly limited dexterity. This is likely to reflect the fact that one contraindication to intermittent catheterisation is poor manual dexterity in the absence of a caregiver (EAU, 2024) and CISC is often not attempted if dexterity is poor. Patients' dexterity can decline over time and some may require extra support.
Below is case study describing a patient experience with reducing dexterity and CISC.
Case study
Nigel White (not his real name) is aged 82 years and a long-term CISC user as he has declined prostate surgery. He is generally happy with performing CISC regularly to manage his urine retention. He has good technique but is beginning to have more difficulty in gripping the catheters he usually uses.
To date, he has been using a 40 cm CISC catheter with a sliding, non-touch grip feature. He now finds the small area and thinness of the sliding grip make it increasingly hard for him to keep hold of the device, causing frequent slips and contamination of the catheter.
Mr White contacted the urology department to ask for help for this problem as he had been using CISC for so long that he was no longer having follow-up appointments. Initially, he was reluctant to try a different catheter as he was so accustomed to his original product and was worried about experiencing problems.
The nurse reassured him that there were a range of alternatives which could help him overcome the problems he was having and provided him with some solutions to try, including sheath CISC catheters. Mr White found a Luja sheath catheter much easier to hold and also said that he felt more confident that he would risk less contamination during handling.
Urinary tract infection
The product evaluation found that 53% of patients had experienced a UTI within the previous year that required antibiotic treatment. However, after using Luja, 75% agreed or strongly agreed they worry less about UTIs resulting from urine left in the bladder and 87% agreed or strongly agreed they did not worry about urine being retained in the bladder. Almost all users (94%) said they will probably or definitely continue to use Luja with 73% stating they would definitely continue to use.
Case study
John Brown (not his real name), aged 30 years, is a bricklayer and keen sportsman. He was referred to the lower urinary tract assessment clinic with voiding symptoms from a private outpatient appointment with a urologist.
He has a history of bulimia (resulting from childhood trauma) which has been under control for years, and hypothyroidism. His medication included pregabalin, naproxen, levothyroxine, fluoxetine, co-codamol and quetiapine fumarate. He had several appointments at the clinic for flow tests but was unable to void. Incomplete emptying was noted, with a large post-void residual volume of >500 ml. Kidney function was checked and normal. He was taught intermittent self-catheterisation and advised to carry it out 5-6 times per day, keeping a note of the volumes. Urodynamic studies had shown poor detrusor function, with the first sensation occurring at 588 ml; filling continued up to 670 ml with no increased urge. Magnetic resonance image and computer tomography of the kidneys and flexible cystoscopy showed no abnormalities.
Mr Brown had his first UTI 3 months after starting self-catheterisation and, despite good technique, multiple reviews and trials of different catheters, his frequency of UTIs increased. Prophylactic antibiotics were prescribed but, despite this, he had six confirmed UTIs in 2023. He had repeat cystoscopy, which was normal.
Mr Brown then had an inpatient episode in the mental health ward where he developed a UTI that was poorly managed and he ended up being sent from the ward to A&E. His UTIs had a significant impact on him and exacerbated his underlying mental health issues. His mother contacted the urology nurses at this stage and he was reviewed. Luja had just been launched and the new technology and the rationale were explained to him. Because of his multiple UTIs and experience, he had little hope of it working but was willing to try.
It was introduced in August 2023; technique and timings stayed the same. He has had no confirmed UTIs since (up to the time of writing). He found the flow of urine improved and prophylaxis were stopped, and he reported it as ‘life-changing’ as it took away his worry of UTIs, improved his quality of life and ability to go about usual activities. He could also accept invitations without the fear, pain and irritation he previously experienced with UTI symptoms or worry of getting one. He was reassured by using the new catheter he had emptied his bladder to completion and noted on first use ‘a better flow’.
User experience of self-catheterisation with Luja
As well as the case studies above written by a health professional as part of the product evaluation, a patient was willing to share his experience. This brings home the impact of having to carry out CISC on quality of life and how debilitating UTIs can be. It also underlines the great impact of product selection on the patient and how the correct choice can contribute to a ‘positive mindset’ and improved quality of life.
Patient story
Receiving a diagnosis of benign prostate hyperplasia more than 5 years ago signified a change to my life as I was introduced to CISC as a way to manage urine retention.
I was not offered a choice of catheter but was handed five and, after a quick ‘this is how you should do it’, talk I was sent home to try them. The catheters worked well insomuch that I was able to use them on an evening, enabling me to sleep without disruption, which had been an issue before my diagnosis.
I had anxieties about catheter use as my need increased. I felt restricted as to where I could go socially if I knew I would need to pass urine. The cumbersome nature of the catheters increased my anxiety as it was difficult to discreetly go to the toilet and I became very self-conscious at this time. I encountered hostility at a concert venue on one occasion; there was a queue at the toilet and, as a space became vacant at the urinal, I had to explain that I was waiting to use the only cubicle to be free, which brought about ridicule from a group of men behind me who offered offensive suggestions as to why I needed to use a cubicle.
I felt benefits from performing CISC. However, I was not prepared for the intensity or frequency of UTIs that arose. I was unaware of them and the first time I experienced a UTI, it presented with fever-like symptoms and shivers with a sensation of urgency and stinging pains in my urethra and bladder. Antibiotics were helpful to fight the infection but other aspects of UTIs became troublesome. Dribbling and needing to use pads made me self-conscious and provided a warm, damp environment, which possibly contributed to the infection. Feeling ‘dirty’ and not wanting to explain to colleagues why I was not well enough for work had a psychological impact and reduced my social activity. The UTIs recurred, despite good hygiene and precautionary actions.
I used the internet to seek an alternative catheter and located some products from Coloplast. I found these were more comfortable for me both physically and psychologically as they were much more discreet and user-friendly. They also greatly reduced the frequency of UTIs. I was then fortunate enough to trial Luja male intermittent catheters and have found them a revelation as I am now able to manage my urine retention issue with more confidence.
I presently have to use a catheter 4–5 times daily owing to a deterioration in my condition, so comfort, ease of use and reduced UTIs are paramount to me. The Micro-hole Zone Technology in the Luja ensures I am totally empty with no need to reposition myself when using a catheter; this speeds up the process immensely. The flow of urine is greatly increased too compared to the two-eyelet catheter psychologically I feel like I am having a ‘proper wee’ as I could in my younger days.
Luja is also handy and discreet to use, which minimises the stigma I felt from using previous, more cumbersome, catheters. Knowing I am empty once I have used a Luja catheter also contributes to a positive mindset as I know that I have no residual urine that can contribute to further UTIs and this has removed the black cloud that previously hung over me. I feel reassured and comfortable using this catheter. It has improved my quality of life as I can go to places with minimal concern and do not have to take as many days off work because of UTIs which provides me with a sense of normality again.
Conclusion
Incontinence is a global issue with many causes. A main cause is residual urine being left in the bladder. This can occur for a variety of reasons. The gold standard for treatment for incomplete bladder emptying either in the long term or while awaiting surgical intervention is CISC.
CISC, while the gold standard, has implications for the patient and complications can arise, with the main one being UTIs. This can be debilitating, affect compliance and have a negative impact on patients' quality of life. The conventional two-eyelet catheter may leave residual urine, cause micro-trauma and lead to haematuria.
A catheter with Micro-hole Zone Technology has been devised with the aim of addressing these complications. Preclinical studies, clinical studies and product evaluations have proven it to be effective in doing this. The Micro-hole Zone Technology behind new Luja catheter has demonstrated efficacy in fully emptying the bladder with less micro-trauma and haematuria than conventional two-eyelet catheters. User experience of both patients and health professionals has confirmed the clinical findings and, when introduced as an alternative, the Luja catheter has resulted in a vast improvement to patients' quality of life.
The Luja catheter is presently available only for men in the UK. A female Luja catheter was launched in Denmark and Italy in May 2024 and is expected to become available in the UK in the next 12 months.
KEY POINTS
- Clean intermittent self-catheterisation is the gold standard for managing urine retention but there are complications associated with performing it
- Complications of clean intermittent self-catheterisation include haematuria, bladder stones and urinary tract infections. These infections are the most common and they can significantly affect patients' quality of life
- Common causes of urinary tract infection include bladder trauma, poor hygiene and residual urine
- A new catheter to the market (Luja) which uses Micro-hole Zone Technology rather than much larger eyelets is intended to address the complications
- Product evaluations involving health professionals and examining patient experiences show this technology is effective in reducing complications
CPD reflective questions
- What can you do to enhance the quality of life of patients who experience complications with clean intermittent self-catheterisation (CISC)?
- Are there particular complications in your patients who carry out CISC that you recognise or are difficult to manage?
- Do you struggle with promotion of adherence to CISC and providing solutions in patients experiencing complications?
- Considering the clinical evidence and case studies in this paper, could Luja be a potential solution in addressing some of complications associated with CISC?