Single-Use vs Reusable Catheters for Intermittent Catheterization in Patients With Urinary Retention: The COMPARE Randomized Clinical Trial.

IMPORTANCE

Clean intermittent catheterization (CIC) is the preferred management for urinary retention. Single-use catheters generate substantial environmental and financial burdens, whereas evidence on the safety of reusable catheters is limited.

OBJECTIVE

To examine whether reusable catheters are noninferior to single-use catheters for CIC with respect to urinary tract infection (UTI) incidence.

DESIGN, SETTING, AND

PARTICIPANTS

This multicenter, noninferiority randomized clinical trial was conducted between February 21, 2020, and April 3, 2025, at 12 Dutch hospitals and included patients aged 16 years or older performing CIC at least twice daily, with 1-year follow-up.

INTERVENTIONS: Participants were randomly assigned to reusable or single-use catheters. Reusable catheters were disinfected daily in 2% sodium hypochlorite solution, rinsed before and after use, and replaced every 2 weeks; single-use catheters were permitted for 20% or less of weekly catheterizations in the reusable group.

MAIN OUTCOMES AND MEASURES: The primary outcome was UTI incidence per patient-month. Secondary outcomes included catheter-related complications, adverse events, and patient-reported outcomes. The noninferiority margin was set at an absolute difference of 0.07 UTIs per patient-month.

RESULTS

A total of 386 patients (mean [SD] age, 61.4 [15.9] years; 243 [63%] male; and 139 [36%] with neurogenic lower urinary tract dysfunction) were included. In the reusable catheter group, 72 of 185 participants (39.0%) discontinued study participation, mainly due to reduced ease of use and urethral irritation. In the modified intention-to-treat population (n = 326), mean (SD) follow-up was 12.0 (1.9) months in the single-use group and 11.4 (2.9) months in the reusable group. During this period, 1 or more UTIs occurred in 59 of 191 single-use catheter users (30.9%) and 40 of 134 reusable catheter users (29.9%). The incidence rate was 0.054 (95% CI, 0.040-0.069) vs 0.050 (95% CI, 0.035-0.067) UTIs per patient-month, with an absolute difference of -0.004 (95% CI, -0.025 to 0.019), meeting the predefined noninferiority margin. Catheter-related complications and serious adverse events were comparable between groups, whereas low-grade adverse events, mainly urethral irritation, were more frequent in the reusable group (37 [20.0%] vs 9 [4.7%]). 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 did not differ between groups.

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of patients with urinary retention, reusable catheters were noninferior to single-use catheters for UTIs, with variable tolerability and patient-reported outcomes highlighting the importance of individual preference and the need for design enhancements to improve usability and broaden implementation.

TRIAL REGISTRATION: National Trial Register: NL8296.