Estudio piloto unicéntrico, doble ciego, aleatorizado y controlado con placebo para evaluar el uso de Canoxidin® en la prevención de la incrustación de la sonda en pacientes portadores de sonda permanente

Abstract

Introduction and objectives

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.

Patients and methods

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.

Results

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 = .016). No adverse effects attributable to the treatment were reported.

Conclusions

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.