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Coloplast has finalised its first pivotal clinical study on Luja, a new intermittent male catheter, designed to reduce the risk of urinary tract infections by minimising residual urine and reducing bladder microtrauma¹.

The study’s primary endpoints were urinary flow-stop episodes and residual volume at first flow-stop. A flow-stop occurs when bladder mucosa is sucked into the catheter eyelets, thereby blocking the urine flow. A blockage requires repositioning of the catheter in order to resume the urine flow to empty the bladder². Additionally, hematuria was assessed by dipstick, and post-catheterisation volume of residual urine was measured with an ultrasound bladder scanner.

Statistically significant results

A selection of the data from the study, which showed statistically significant results, was presented at the United Kingdom Continence Society (UKCS) Annual Scientific Meeting in Sheffield, UK, on 30 March³:

• Catheterisation with Luja resulted in close to zero flow-stops compared to one flow-stop on average with VaPro*.
  
  
• Luja achieved complete bladder emptying* in 90% of catheterisations, while VaPro achieved this in 52% of catheterisations.
  
  
• Catheterisation with Luja resulted in a 74% less likelihood of hematuria post-catheterisation, compared to VaPro.
  
  

"I am very pleased with the results of the Luja CP353 study. All primary and secondary endpoints have been successfully met, and the study clearly demonstrates that Luja significantly improves bladder emptying. I am excited by what Luja can do for people who use intermittent catheters to empty their bladder, and I look forward to following the launch in the coming months," says Nicolai Buhl, Executive Vice President of Innovation at Coloplast.

The CP353 study

Urinary tract infections represent a significant challenge for people who use intermittent catheters to empty their bladder, and on average users experience 2-3 urinary tract infections per year^1,4. Almost half of intermittent catheter users are unsure whether their bladder has been fully emptied after catheterisation⁴. 

When emptying the bladder with conventional eyelet catheters, the flow of urine can be interrupted because the bladder mucosa surrounding the eyelets is sucked into the catheter**. These flow-stops can give users the false impression that their bladder is empty³, potentially leading to premature removal of the catheter and residual urine left behind in the bladder. To release the mucosa from the eyelets, and resume flow, users are required to reposition the catheter which can result in microtrauma**. Residual urine and microtrauma are both important risk factors for urinary tract infections^1,,5-6. Consequently, users of conventional eyelet catheters are exposed to both these risk factors¹ when they perform their catheterisation. 

The CP353 study investigated the performance of Coloplast’s new intermittent male catheter, Luja, with 80+ micro-holes designed to reduce urinary flow-stops and minimise residual urine. The investigation was a single-centre, crossover, randomised and controlled study, which consisted of one inclusion visit and two single test visits. A total of 42 subjects enrolled were catheterised by a healthcare professional with a Luja catheter and a VaPro catheter ³. 

You can find the data set presented at the UKCS Annual Scientific Meeting via this link.

The Luja launch

The launch of CE-marked Luja is progressing well. Denmark and Finland were the first launch markets initiated as of February, to be followed by launch in Italy and the Netherlands in April. The product is expected to be available across Coloplast’s key markets over the next 12 months. Coloplast has finalised the second pivotal clinical study on Luja, the results of which are expected to be publicly available within the next few months.

CONTACTS
Peter Mønster
Sr. Media Relations Manager, Corporate Communications
+45 4911 2623
dkpete@coloplast.com

Aleksandra Dimovska
Director, Investor Relations
+45 4911 2458
dkadim@coloplast.com

Luja is a medical device for which CE-mark has been affixed. Product availability is subject to regulatory process of individual countries and is not guaranteed.

* Luja has close to zero flow stops. Complete bladder emptying is defined as <10 mL (CP353, NCT05485922). After catheterisation, both catheters emptied the bladder to low and comparable residual volume post-catheterisation levels (meaning values for both Luja and VaPro were <8 mL).

**Tested in a pre-clinical setting (ex vivo)

REFERENCES 

1. Kennelly M, et al. Adult Neurogenic Lower Urinary Tract Dysfunction and Intermittent Catheterisation in a Community Setting: Risk Factors Model for Urinary Tract Infections. Advances in urology. 2019:2757862

2. Vahr et al. Catheterisation Urethral Intermittent in Adults. Arnhem, Netherlands: European Association of Urology Nurses (EAUN); 2013.

3. M.H. Landauro, et al. Micro-hole zone technology shows superior ability to empty the bladder: a crossover randomised controlled trial in users of intermittent catheters. UKCS Annual Scientific Meeting; Sheffield, United Kingdom 2023.

4. Islamoska et al. Nov 2022. Patient-reported risk factors for urinary tract infections are associated with lower quality of life among users of clean intermittent catheterisation. Poster at BAUN (Coloplast user survey 2022 (n=3464)

5. Grabe et al. Guidelines on urological infections. EAU Guidelines presented at the 26th EAU Annual Congress, Vienna. 2013:78-93.

6. Vasudeva and Madersbacher. Factors implicated in pathogenesis of urinary tract infections in neurogenic bladders: some revered, few forgotten, other ignored. Neurourol Urodyn. 2014;33(1):95-100.

Link to clinical trial: https://clinicaltrials.gov/ct2/show/NCT05485922?term=NCT05485922&draw=2&rank=1
Link to Kennelly article: https://www.hindawi.com/journals/au/2019/2757862/

Urinary tract infections represent a significant challenge for people who use intermittent catheters to empty their bladder. This includes people living with spinal cord injury, multiple sclerosis, or spina bifida. On average, intermittent catheter users have 2-3 urinary tract infections per year^1-3, which can lead to serious health complications⁴, have a significant impact on quality of life², and result in hospitalisation^5-9, thereby putting pressure on local healthcare systems.

Complete bladder emptying in one free flow

Coloplast is now launching Luja, the first and only male catheter featuring 80+ micro-holes, aiming to address important UTI risk factors¹ linked to intermittent catheterisation.

“The primary function of a catheter is to empty the bladder. Still, people experience urine flow stops and blockage of the catheter eyelets during bladder emptying with the conventional catheters on the market today¹⁰”, says Executive Vice President of Innovation at Coloplast, Nicolai Buhl.

Flow stops and blockage of the catheter eyelets during emptying increase the risk of leaving residual urine behind in the bladder. Residual urine increases the risk of bacteria growth and is a well-known UTI risk factor¹.

“With Luja and its Micro-hole Zone Technology we are setting a new standard for intermittent catheterisation and ensuring complete bladder emptying in one free flow^*. We believe this catheter will be a paradigm shift within continence care and benefit catheter users as well as healthcare systems as a whole,” ends Nicolai Buhl.

The launch of Luja begins this month, February, in Denmark and Finland, and the product is expected to be available across Coloplast’s key markets over the next 12 months**. Coloplast is currently conducting two pivotal clinical studies to document and demonstrate the benefits of Luja. The results are expected to be publicly available within the next few months.

A growth driver in continence care

In 2021/22, the global market for continence care products was worth an estimated 15-16 billion DKK with an underlying annual market growth of 5-6%. Coloplast is the global market leader in continence care, and the company continues to outgrow the market and take market share. The launch of Luja is expected to contribute to Coloplast’s growth trajectory and help solidify the company’s global market leader position. 

* Luja has close to no flow stops and complete bladder emptying is defined as <10 mL (CP353, NCT05485922)
**Luja is a medical device for which CE-mark has been affixed. Product availability is subject to regulatory process of individual countries and is not guaranteed.

1. Kennelly M, Thiruchelvam N, Averbeck MA, Konstatinidis C, Chartier-Kastler E, Trøjgaard P, et al. Adult Neurogenic Lower Urinary Tract Dysfunction and Intermittent Catheterisation in a Community Setting: Risk Factors Model for Urinary Tract Infections. Adv Urol. 2019;2019:2757862.

2. Islamoska S, Landauro MH, Zeeberg R, Jacobsen L, Vaabengaard R. Patient-reported risk factors for urinary tract infections are associated with lower quality of life among users of clean intermittent catheterisation.  BAUN; Edinburgh2022.

3. Flores-Mireles AL, Walker JN, Caparon M, Hultgren SJ. Urinary tract infections: epidemiology, mechanisms of infection and treatment options. Nat Rev Microbiol. 2015;13(5):269-84.

4. Salomon J, Gory A, Bernard L, Ruffion A, Denys P, Chartier-Kastler E. [Urinary tract infection and neurogenic bladder]. Prog Urol. 2007;17(3):448-53.

5. Biering-Sørensen F, Bagi P, Høiby N. Urinary tract infections in patients with spinal cord lesions: treatment and prevention. Drugs. 2001;61(9):1275-87.

6. Biering-Sørensen F. Urinary tract infection in individuals with spinal cord lesion. Curr Opin Urol. 2002;12(1):45-9.

7. Scotland KB, Lange D. Prevention and management of urosepsis triggered by ureteroscopy. Res Rep Urol. 2018;10:43-9.

8. Gabbe BJ, Nunn A. Profile and costs of secondary conditions resulting in emergency department presentations and readmission to hospital following traumatic spinal cord injury. Injury. 2016;47(8):1847-55.

9. The 2021 Annual Statistical Report. Complete Public Version for the Spinal Cord Injury Model Systems. National Spinal Cord Injury Statistical Center, Birmingham, Alabama; 2021.

10. Tentor F, Grønholt Schrøder B, Nielsen S, Schertiger L, Stærk K, Emil Andersen T, et al. Development of an ex-vivo porcine lower urinary tract model to evaluate the performance of urinary catheters. Sci Rep. 2022;12(1):17818.