Single-center, double-blind, randomized, placebo-controlled pilot study of Canoxidin® for prevention of catheter encrustation in patients with indwelling catheters

• Published in: Actas urológicas españolas (English ed.) 2024-11, Vol.48 (9), p.658-664
• Main Authors: Borau, A., Amaya, E., Delía, P., Alves, M.J., Morcillo, M., Ustrell, A., Opisso, E.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Catheter encrustation; Catheters, Indwelling - adverse effects; Catéter Foley; Double-Blind Method; Female; Fitato; Foley catheter; Humans; Incrustación de la sonda; Male; Methionine; Metionina; Middle Aged; Phytate; Pilot Projects; Prevención; Prevention; Teobromina; Theobromine; Urinary Catheterization - adverse effects; Urinary Catheters - adverse effects
• ISSN: 2173-5786; 2173-5786
• DOI: 10.1016/j.acuroe.2024.06.004

[Display omitted] Long-term use of an indwelling catheter is associated with complications such as catheter encrustation and infection. Canoxidin® is a novel oral treatment that can potentially prevent catheter encrustation, as it contains a urine acidifier and a combination of two crystallization inhibitors. This study aimed to evaluate the effects of Canoxidin® on catheter encrustation in patients with indwelling Foley catheters. This was a single-center, double-blind, randomized, placebo-controlled study. Neuro-urology patients aged ≥18 years with an indwelling catheter (urethral or suprapubic) were randomized to treatment consisting of either Canoxidin® or placebo for one month. Foley catheters (two per patient, one before treatment and one after treatment) were removed for analysis of the presence and degree of encrustation. A total of 40 patients were enrolled and randomized, 28 of whom had analyzable catheters (13 assigned to Canoxidin® and 15 assigned to placebo). The patients had a mean age of 51.8 years, and eight (28.6%) were female. Two patients (13.3%) in the placebo group and eight patients (61.5%) in the Canoxidin® group experienced an improvement (less encrustation). There was a significant association between Canoxidin® and improvement (odds ratio: 10.4, 95% confidence interval: 1.6 to 66.9, P = 0.016). No adverse effects attributable to the treatment were reported. The overall rate of catheter encrustation was high among those with indwelling Foley catheters. One-month treatment with Canoxidin® reduced the formation of these encrustations, with an excellent short-term safety profile. El uso prolongado de una sonda se asocia a complicaciones como la incrustación y las infecciones. Canoxidin® es un novedoso tratamiento oral que puede prevenir la formación de incrustaciones sobre la sonda, ya que combina la acción de un acidificante de la orina con dos inhibidores de la cristalización. El objetivo de este estudio era evaluar los efectos de Canoxidin® en las incrustaciones de las sondas en pacientes portadores de catéter Foley de larga duración. Se realizó un estudio unicéntrico, doble ciego, aleatorizado y controlado con placebo. Los pacientes neurourológicos de ≥18 años, portadores de una sonda permanente (uretral o suprapúbica) fueron asignados aleatoriamente a tratamiento con Canoxidin® o placebo durante un mes. Se retiraron las sondas (dos por paciente, una antes del tratamiento y otra después) para analizar la presencia y el grado de in