The efficacy of super-lubricous Foley catheters in indwelling catheterization: a randomized controlled trial

This randomized controlled trial evaluated the clinical efficacy of super-lubricous Foley catheters in reducing urethral complications during indwelling catheterization. Focusing on addressing friction-induced injuries, the study assessed four outcomes: 1) urethral adverse reactions; 2) urethral trauma and inflammatory responses; 3) patient comfort; and 4) post-removal voiding symptoms.

A total of 114 patients from a tertiary hospital (December 2023-June 2024) were randomly allocated into two arms: 57 individuals in the experimental arm were treated with super-lubricous Foley catheters, whereas the same number in the control arm received conventional catheters. Primary outcomes included bladder irritation and urethral pain. Secondary outcomes encompassed urethral injury (red blood cells and epithelial cells), inflammation (white blood cells), comfort metrics (activity restriction, sleep disturbance, anxiety), and voiding parameters (dysuria, urinary hesitation, incomplete bladder emptying and lower abdominal pain).

The baseline data revealed no statistically meaningful differences between the two groups. (all P > 0.05). The experimental group demonstrated significantly lower overall rates of bladder irritation (31.6% vs. 50.9%, P < 0.05) and urethral pain during catheterization (14.0% vs. 31.6%, P < 0.05). Notably, urinary epithelial cells (median 6 vs. 13.5/HP) and leukocytes (31 vs. 81/μL) were reduced in the experimental group (P < 0.05). Activity restriction rates decreased significantly (42.1% vs. 68.4%, P < 0.05), and first void volume improved (200 vs. 150 mL, P < 0.05). There were no meaningful differences between groups in the occurrence of the four urination-related symptoms-including dysuria, urinary hesitation, incomplete bladder emptying, and lower abdominal pain (all P > 0.05).

Super-lubricous Foley catheters effectively mitigate bladder irritation, urethral trauma, and inflammation while enhancing patient mobility. However, they show limited efficacy in alleviating post-removal voiding dysfunction. These findings support the clinical adoption of super-lubricous Foley catheters for reducing catheterization-related complications.

This study was a randomized controlled trial registered at Chinese Clinical Trial Registry (ChiCTR2300078483, https://www.chictr.org.cn/ ) on 11 December 2023.