Intermittent catheterisation (IC) is the standard method for managing voiding dysfunction. Globally single-use catheters and multi-use (reusable) ones are used. Using both types (mixed-use) could bring benefits (e.g. reducing plastic waste) and offer more choice to patients. This study aimed to determine if Mixed use is as safe as Single-use only for urinary tract infection (UTI) and user acceptability.

This non-inferiority randomised controlled trial (RCT) aimed to recruit 578 community-dwelling, adult IC users (men and women ≥ 18 years) UK-wide. Participants were randomised 1:1 to either Mixed-use (intervention) or Single- use (control). Follow-up was a monthly phone call for 12 months.

Inclusion criteria: included adults self-catheterising (or IC by sole carer) at least daily for >six weeks.

Exclusion criteria: included self-dilatation without bladder drainage, IC via Mitrofanoff, current or planned pregnancy.

Primary outcome: at least one episode of Microbiologically Confirmed Symptomatic Urinary Tract Infection with Help-seeking or Self-help behaviour (MCS-UTI+HS) over 12-months. Laboratory analysis of patient-initiated urine samples was blind.

Secondary outcomes included rate of MCS-UTI+HS, antibiotic use, microhaematuria, visible blood on catheter/in urine and quality of life (QoL).

Intervention: Mixed use comprised participant’s usual single-use catheters plus at least daily use of the Cliny reusable catheter (Create Medic Co., Ltd.) cleaned between uses with a fully tested, chlorine-based cleaning method (1) for up to 28 days and then replaced. Lubricant gel was used as desired by participants. All products required for the intervention (except single-use catheters) were provided.

Ethics approval: South Central - Hampshire A Research Ethics Committee 12/07/2019 (reference: 19/SC/0334). Written, informed consent to participate was obtained from all participants.

578 community-dwelling IC users were randomly assigned to Mixed-use (n=289) or Single-use (n=289). The per protocol analysis found at least one episode of MCS-UTI+HS over 12 months occurred in 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 IRR (95% CI):0·65 (0·45, 0·95). Participants re-used a median of 2·8 (IQR: 1·8, 3·9) times per day.

There was evidence of difference favouring Single-use for urethral ‘sticking’. QoL and adverse events were similar across both groups.

MultICath is the first randomised controlled trial adequately powered to compare using a combination of reusable and single-use catheters with single-use catheters only for non-inferiority and adds to the evidence base for reusable compared to single-use catheters which has been characterised by a lack of robust data.

The Mixed-use group took fewer antibiotics than the Single-use group. Strategies worldwide seek to reduce antibiotic use to tackle antimicrobial resistance described by WHO as one of the top global public health and development threats.

Single-use only participants reported less sticking. The silicone Cliny catheter was observably less smooth and required an external lubricant. We do not know the clinical importance of sticking and there was no evidence of more pain/discomfort or visible blood to indicate urethral trauma.

QoL was measured using the ISC-Q tool (2). We found no evidence of a difference in QoL scores indicating that when patients can choose their frequency of reuse as part of mixed-use, QoL is not likely to be compromised.

Using a combination of reusable and single-use catheters is non-inferior to using only single-use catheters for UTI, is associated with lower antibiotic use and does not reduce QoL. Reusable catheters can be offered as a choice for intermittent catheter users.

Wilks S, Macaulay M, Prieto J, Avery M, Bryant C, Delgado D, Murphy C, Morris N, Fader M. How to clean a catheter: Development of an intervention for intermittent catheter reuse. BJUI Compass. 2025 Feb 4;6(2):e487. doi: 10.1002/bco2.487. PMID: 39917585; PMCID: PMC11794242.
Pinder B, Lloyd AJ, Elwick H et al. Development and psychometric validation of the intermittent self-catheterization questionnaire. Clinical therapeutics 2012; 34(12): 2302-13.