Devicare and nine leading Spanish hospitals in urology have successfully completed the clinical trial which demonstrates the efficacy of the combined use of a medical device (Lit-Control® pH Meter) and a nutraceutical (Lit-Control® pH Down) to prevent the encrustation of double J catheters by monitoring urinary pH and supplying phytates (crystallisation inhibitors).

The results of this pioneering study at the international level will be presented in the Meeting of the Groups of Lithiasis, Endourology, Laparoscopy and Robotics Meeting of the Spanish Association of Urology in January in Palma de Mallorca and in the European Association of Urology Congress in March in Barcelona in front of more than 10,000 urologists. The solution provides a response to an unresolved medical need which affects an important part of the patients affected by urolithiasis.

“These clinically significant results show that we have a solution that will help medical practice and make it easier to manage patients with a double J catheter implant. It will be a true revolution” explained Dr Carlos Torrecilla, the principal investigator of the trial, director of the Lithiasis Unit of the Bellvitge University Hospital and coordinator of the Lithiasis and Endourology Group of the Spanish Association of Urology (AEU).

A total of 105 patients participated in the multicentre, randomised, double-blind, placebo-controlled trial conducted this year in Bellvitge, the La Paz University Hospital in Madrid, the Río Hortega University Hospital in Valladolid, the Puigvert Foundation, the San Cecilio University Hospital in Granada, the Valme University Hospital in Seville, the Álvaro Cunqueiro Hospital in Vigo, the La Fe University Hospital in Valencia and the Santiago de Compostela University Hospital, with the participation of the Lithiasis Laboratory of the University of the Balearic Islands.

Finding solutions for other urological diseases

The innovative focus of Lit-Control® has generated great interest from the medical-scientific community both in how the study was conducted as well as its results. In addition to proving the product’s clinical efficiency, doctors have gained greater insight into the encrustation process, thanks in part to the important role of Dr Fèlix Grases and Dr Antonia Costa of the Lithiasis Laboratory of the University of the Balearic Islands.

In the words of Dr Jordi Cuñé from the Devicare scientific team, this trial is considered “a resounding success as it validates the working hypothesis and reinforces our firm commitment to providing innovative solutions in the field of urology”. The scientific and technological basis that the trial has achieved “will allow us to delve into the field of catheters, as well as to approach other unmet needs such as preventing Catheter Associated Urinary Tract Infections” Cuñé added. These types of patients are extremely prevalent within the geriatric population with spinal cord damage or cognitive impairment and with lateral impacts such as high antibiotic consumption and the associated antibiotic resistance.

In recent years, Devicare has designed an ambitious development programme for nutraceuticals and medical foods: “we want to provide the most rigorous clinical evidence with the collaboration of the best urologists, as has been the case in the double J study” Jordi Cuñé noted.

What is the double J catheter?

The double J stent catheter is a tube-shaped device, with a small diameter, made of different materials such as silicone, which is implanted in patients to facilitate the passage of urine from the kidney to the bladder when the ureter is obstructed by a stone as well as to prevent this obstruction. Patients may have a catheter for a few days, weeks or months.

Additionally, its use is also widely spread in the medical management of benign or malignant chronic obstructions, transplants, malformations or in palliative referral. In these cases the catheter may be implanted for long periods of time, even their entire lifetime, and is very susceptible to infectious processes and incrustation.

In Spain alone, around 90,000 double J catheters are implanted each year, being encrustation one of the most common issues. Due to dietary changes, the increased global temperature and other unidentified factors, we are observing an increase in the rate of kidney lithiasis (1).

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(1) Sorokin I., Mamoulakis C., Miyazawa K., Rodgers A., Talati J., Lotan Y. (2017). Epidemiology of stone disease across the world. World J Urol. doi: 10.1007/s00345-017-2008-6.