Effectiveness of the NowCath Foley in Reducing Catheter-Associated UTIs and Blockages in Long-Term Indwelling Catheter Users (REDUCE)

Background

Adults who depend on long-term indwelling urethral or suprapubic Foley catheters in the community setting frequently experience catheter-associated urinary tract infections (CAUTIs), catheter blockages, and unscheduled catheter changes. These complications are associated with increased antibiotic exposure, hospital and emergency visits, morbidity, and impaired quality of life. Antimicrobial coatings and other design modifications tested to date have shown limited long-term benefit. Two of the pathophysiological drivers of these complications are incomplete bladder emptying, which leaves a residual reservoir that supports bacterial growth and crystalline precipitation, and mucosal contact with the drainage eyelets, which can cause local trauma and inflammation.

Investigational Device

The NowCath Foley is an all-silicone indwelling urinary catheter conforming to ISO 20696 and ASTM F623. It differs from a conventional all-silicone Foley catheter in two respects: two additional drainage eyelets positioned below the retention balloon, and a thin flexible silicone skirt that covers these eyelets to reduce mucosal suction. The device is intended for long-term (up to 90 days) indwelling urethral or suprapubic use.

Comparator

A commercially available, CE-marked all-silicone Foley catheter (Rüsch Brillant, Teleflex Medical) representing the current standard of care.

Regulatory Framework

The study is a pre-market pivotal clinical investigation conducted under Regulation (EU) 2017/745 (MDR) in accordance with ISO 14155:2020 and the Declaration of Helsinki. A clinical evaluation concluded that additional clinical data are required to confirm compliance with the relevant General Safety and Performance Requirements.

Primary Hypothesis

The NowCath Foley reduces the incidence of catheter changes per 100 catheter days compared with a conventional all-silicone Foley catheter in long-term indwelling catheter users.

Objectives

Primary: To compare the incidence of catheter changes per 100 catheter days during the first 4 weeks of each 12-week treatment phase between the NowCath Foley and the comparator catheter.

Co-primary: To compare the incidence of catheter changes per 100 catheter days over the full 12-week phase between the two catheters.

Secondary: To compare CAUTI incidence, blockage requiring catheter removal, residual urine volume, time to first asymptomatic bacteriuria, catheter encrustation severity, antibiotic use, catheter-related quality of life (ICIQ-LTCqol), general health-related quality of life (EQ-5D-5L), patient comfort and satisfaction, study-coordinator-reported ease of insertion, participant preference, and within-trial cost-effectiveness.

Safety: To monitor adverse events, adverse device effects, serious adverse events, serious adverse device effects, and catheter-related complications (including urethral trauma, bladder trauma, haematuria, allergic and skin reactions), classified per ISO 14155:2020.

Study Design

Multi-centre, prospective, randomized, blinded, controlled crossover clinical investigation. Each participant undergoes two consecutive 12-week treatment phases in a randomly assigned sequence (NowCath Foley then comparator, or comparator then NowCath Foley), allocated 1:1. There is no washout between phases; the crossover coincides with a scheduled catheter change. Patients, treating physicians, and community-nursing personnel are blinded to catheter allocation through use of identical over-labelling; study coordinators and the principal investigator are unblinded for safety and logistical oversight.

Population

Adults (≥18 years) receiving community nursing care from Ikast-Brande or Holstebro municipalities in Denmark, with an indwelling urethral or suprapubic Foley catheter in place for ≥28 days at enrolment and an expected need for continued catheterization for at least 6 months.

Key inclusion criteria: age ≥18 years; indwelling catheter use ≥28 days; planned catheter continuation for ≥6 months; no systemic antibiotic treatment for CAUTI within 48 hours prior to enrolment; written informed consent.

Key exclusion criteria: known allergy or hypersensitivity to silicone or glycerin; straight-tip catheterization considered clinically unsuitable; planned continuation of prophylactic antibiotics for frequent CAUTI; ureteric stents or planned genito-urinary procedures during the study period; pregnancy, lactation, or planned pregnancy during the study period.

Sample Size

A total of 160 participants will be enrolled. The sample size was determined by simulation to provide 90% power at a two-sided 5% significance level to detect the assumed between-catheter difference on the primary endpoint. Assumptions: a background incidence of 1.536 catheter changes per 100 catheter days for the conventional catheter (Wilde MH et al., Res Nurs Health 2017), a 60% reduction in CAUTI- and blockage-related changes with the NowCath Foley (dislodgement rate unchanged), and 25% withdrawal over 24 weeks. The paired between-catheter comparison uses a Wilcoxon signed-rank test. Simulation indicated 148 evaluable participants; 160 will be enrolled to accommodate first-phase dropouts.

Endpoints

Primary endpoints: incidence of catheter changes per 100 catheter days during the first 4 weeks of each phase; incidence of catheter changes per 100 catheter days over the full 12 weeks of each phase.

Secondary endpoints: ICIQ-LTCqol at weeks 0, 12, and 24; EQ-5D-5L at weeks 0, 12, and 24; residual urine volume by bladder scan at weeks 12 and 24; time to first asymptomatic bacteriuria; CAUTI incidence per 100 catheter days; blockage incidence requiring catheter removal per 100 catheter days; catheter encrustation score (0-12 visual scale) and proportion with severe encrustation (grade ≥3), with photographic documentation of removed catheters; antibiotic use overall and per CAUTI guidelines; within-trial incremental cost-effectiveness ratio per catheter change prevented; participant comfort and satisfaction; study-coordinator-reported ease of insertion (1-10 scale).

Safety endpoints: number and category of adverse events, adverse device effects, serious adverse events, serious adverse device effects, and catheter-related complications.

Exploratory endpoints: bacterial species identified in CAUTI episodes; blinding integrity assessed by questionnaire at week 24.

Statistical Analysis

The intention-to-treat population, comprising all randomized participants analysed according to assigned sequence, is the primary analysis population. Primary endpoints are analysed using the Wilcoxon signed-rank test on within-participant paired differences in catheter-change rates. Multiplicity across the two co-primary endpoints will be controlled through a pre-specified hierarchical testing strategy defined in the statistical analysis plan. Secondary endpoints are pre-specified but not formally powered.

Study Duration

Each participant is followed for 24 weeks (two 12-week phases) plus screening and close-out. Clinic visits occur at week 0 (baseline), week 12 (crossover catheter change), and week 24 (end of study). Weekly urine sampling (at home or on site) is performed at weeks 1-11 and 13-23. Additional telephone contact occurs as clinically indicated.

Sites

Community nursing services of Ikast-Brande and Holstebro municipalities, in collaboration with the Department of Medicine, Regional Hospital Gødstrup, Denmark.

Inclusion criteria

• Adults aged 18 years or older
• Indwelling urethral or suprapubic Foley catheter in place for at least 28 days prior to enrolment
• Expected need for continued indwelling catheterization for at least 6 months
• No systemic antibiotic treatment for CAUTI within 48 hours prior to enrolment
• Written informed consent provided by the participant
• Receiving community nursing care from Ikast-Brande or Holstebro municipalities (or otherwise cared for by their services)

Exclusion criteria

• Known allergy or hypersensitivity to silicone or glycerin
• Straight-tip catheterization considered clinically unsuitable
• Planned continuation of prophylactic antibiotics for frequent CAUTI
• Ureteric stents in place or planned genito-urinary procedures during the study period
• Pregnancy, lactation, or planned pregnancy during the study period