Mixed (reusable/single-use) catheter management versus single-use catheter management for intermittent catheter users (MultICath): A non-inferiority randomised controlled trial.

PURPOSE: To determine if reuse of intermittent catheters is safe for the community management of long-term bladder emptying problems, this trial compared using a combination of reusable and single-use catheters (Mixed-use), to standard practice of single-use catheters only and examined the incidence of urinary tract infections (UTI).

DESIGN

Open label, randomised, non-inferiority trial.

SETTING AND

PARTICIPANTS

Community-dwelling intermittent catheter users aged over 18 were invited to join the Trial by 234 general practices and five community nursing teams across the United Kingdom. The Trial was managed from two university-based trial centres (Southampton and Glasgow) from April 2021 to July 2024.

INTERVENTIONS: Random assignment (1:1) using permuted block sequences via a web-based system to receive either Mixed-use (trial reusable catheters plus participants' own single-use catheters) or Single-use (participants' own single-use catheters) for 12 months. Treatment allocation was masked from microbiology assessors but not participants or researchers.

MAIN OUTCOME MEASURES: The primary outcome was at least one episode of microbiologically confirmed symptomatic UTI (any sign or symptom) with help-seeking or self-help over 12 months. The critical odds ratio for non-inferiority was 2·0. The primary analysis was on a per protocol basis. Secondary outcomes included antibiotic-use, quality of life and participant reported problems with catheterisation.

RESULTS

578 participants were randomly assigned to Mixed-use (n = 289) or Single-use (n = 289). The per protocol analysis comprised 171 participants in Mixed-use and 244 participants in Single-use. The primary outcome of at least one UTI episode over 12 months was met by 49 (28·7%) of 171 participants in Mixed-use and 84 (34·4%) of 244 participants in Single-use. Mixed-use was non-inferior to Single-use (unadjusted odds ratio (95% CI): 0·77 (0·50, 1·17)). Antibiotic use was 35% less in Mixed-use compared to Single-use (adjusted incidence rate ratio (95% CI): 0·65 (0·45, 0·95)). Catheter 'sticking' was significantly worse in Mixed-use compared to Single-use. Participants reused a median of 2·8 (interquartile range: 1·8, 3·9) times per day. Quality of life and adverse events were similar across both groups.

CONCLUSIONS

For the community management of long-term bladder emptying problems, the combined use of reusable and single-use catheters is as safe as using only single-use catheters for UTI and is associated with lower antibiotic use. Reusable catheters can be offered as a safe choice for intermittent catheter users.

TRIAL REGISTRATION: ISRCTN 42028483, 05.09.2019. Trial commenced 19.02.2021.