Reusable noninferior to single-use catheters for patients with urinary retention

For patients with urinary retention requiring clean intermittent catheterization, the use of reusable catheters does not appear to increase the risk of urinary tract infection (UTI) and serious complications when compared with single-use catheters, according to a noninferiority randomized clinical trial.

The 12-month trial included 386 patients (mean age 61.4 years, 63 percent male, 36 percent with neurogenic lower urinary tract dysfunction) who were undergoing clean intermittent catheterization at least twice daily.

The patients were randomly assigned to reusable (n=193) or single-use (n=193) catheters. Reusable catheters were disinfected daily in 2% sodium hypochlorite solution, rinsed before and after use, and replaced every 2 weeks. Patients in the reusable group were allowed single-use catheters for ≤20 percent of weekly catheterizations.

UTI incidence per patient-month was the primary outcome, with the noninferiority margin set at an absolute difference of 0.07 UTIs per patient-month. Secondary outcomes included catheter-related complications, adverse events, and patient-reported outcomes.

The modified intention-to-treat population comprised 326 patients, with a mean follow-up of 12 months in the single-use group and 11.4 months in the reusable group. During this period, UTIs occurred in 30.9 percent of single-use catheter users and in 29.9 percent of reusable catheter users, for an incidence rate of 0.054 vs 0.050 UTIs per patient-month, respectively. The absolute difference of −0.004 met the predefined noninferiority margin.

The incidence of catheter-related complications and serious adverse events was also similar between the single-use and reusable groups. Low-grade adverse events such as urethral irritation were more common in the reusable group (20 percent vs 4.7 percent). Catheter-related quality of life was higher with reusable catheters, whereas catheterization satisfaction was higher with single-use catheters. Overall health-related quality of life was comparable between the two groups.

Notably, there were 39 percent of patients in the reusable group who discontinued study participation due to reduced ease of use and urethral irritation.

The findings indicate that while reusable catheters are as safe as single-use catheters, reusable catheters may not be suitable for all patients.