Devicare and nine leading hospitals in urology have started the pioneering international "Double J" study to evaluate the combined use of a medical device and a nutraceutical in controlling urinary pH and inhibiting crystallisation in order to prevent the calcification of double J stent catheters and reduce the number of associated complications.
"The calcification of a double J stent catheter implant can make surgical extraction complex, while when there are no encrustations it is an operation that lasts a few minutes" explains Dr Carlos Torrecilla, the trial's principal investigator, director of the Lithiasis Unit in the Bellvitge University Hospital and national coordinator of the Lithiasis and Endourology Group of the Spanish Association of Urology.
Each year 90,000 double J stent catheters are implanted in Spain, approximately 25% of which lead to complications. Calcification is one of the common causes, which can lead to the obstruction and encrustation of the catheter and to a greater risk of infections or the impossibility to expel urine.
The clinical trial which has been started up is a multicentre, randomised, double blind, placebo-controlled study, and has been approved by the CREC of Bellvitge. For the study, 105 patients are being recruited in Bellvitge, the Santiago de Compostela Hospital Complex, the Puigvert Foundation, the Valme University Hospital in Sevilla, La Fe University Hospital in Valencia, La Paz University Hospital in Madrid, the Rio Hortega University Hospital in Valladolidad, San Cecilio University Hospital in Granada and Álvaro Cunqueiro Hospital in Vigo.
"Currently we have ample in vitro evidence and from animal models, as well as the clinical efficacy of the products patented by Devicare. However, with the commitment to offer products with the highest level of safety and evidence, we're developing this multicentre study with national references in urolithiasis” explains Dr Jordi Cuñé, Devicare's medical and innovation director.
"We hope to have the final results of the study during the last quarter of 2018 and offer an even more rigorous evaluation of Lit-Control's efficacy for the medical community" he commented.
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 or other causes (malformations, kidney transplant, tumours...), as well as to prevent this obstruction. Patients may have a catheter for a few days, weeks or months, or even their entire lifetime.
More information here: www.cateterdoblejota.com
Foto: Dr. Jordi Cuñé, director médico de Devicare, y Xavier Peris, director de ventas y marketing de Devicare