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

Condition(s) studied

Investigational drug(s) / intervention(s)

NowCath Foley: All-silicone indwelling urinary (Foley) catheter conforming to ISO 20696 and ASTM F623, with two additional drainage eyelets positioned below the retention balloon and a thin flexible silicone skirt covering these eyelets to reduce mucosal suction. Used as an indwelling urethral or suprapubic catheter and changed per standard clinical practice or when clinically indicated.

Conventional All-Silicone Foley Catheter: CE-marked all-silicone indwelling urinary (Foley) catheter representing the current standard of care for long-term indwelling urethral or suprapubic catheterization. Used and changed per standard clinical practice or when clinically indicated.

Study summary

People who rely on long-term indwelling urinary (Foley) catheters often experience recurrent urinary tract infections and catheter blockages that require unscheduled catheter changes, additional antibiotics, and emergency visits. These complications reduce quality of life and increase healthcare use.

The NowCath Foley is an all-silicone indwelling urinary catheter with two additional drainage eyelets positioned below the retention balloon. A thin silicone skirt covers the eyelets to reduce suction against the bladder wall. The design is intended to improve bladder emptying and reduce mucosal contact, which may in turn lower the rate of catheter-associated urinary tract infections (CAUTIs) and blockages compared with a conventional all-silicone Foley catheter.

The REDUCE study is a multi-centre, randomized, blinded, controlled crossover clinical investigation conducted in Denmark. The primary goal is to determine whether the NowCath Foley catheter can reduce incidence of CAUTI over 12 weeks compared to a conventional long-term indwelling Foley catheter in an adult population using indwelling urethral or suprapubic Foley catheters . The participants (n=160) are cared for and enrolled by community nursing services in the Ikast-Brande and Holstebro municipalities in collaboration with the coordinating site at Regional Hospital Gødstrup. Each participant will use both the NowCath Foley and a conventional all-silicone Foley catheter (Rüsch Brillant, Teleflex Medical) in a randomized sequence, for 12 weeks each (24 weeks total).

The primary outcome is the rate of catheter changes per 100 catheter days. Secondary outcomes include CAUTI incidence, blockage incidence, residual urine volume, encrustation, antibiotic use, quality of life, patient comfort, safety, and cost-effectiveness.

During phase 1, participants will be randomised to either NowCath or the conventional Foley catheter and will be seen at weeks 0 and 12. At week 12 participants will be crossed-over to phase 2, where they will receive the other catheter not allocated in phase 1 and will be seen at weeks 12 and 24. As the participants would default to the comparator catheter as part of standard of care, the wash-out period is minimal.

Eligibility

Primary outcome measure(s)

• Incidence of catheter changes per 100 catheter days during the first 4 weeks of each treatment phase — Weeks 0-4 and weeks 12-16 (first 4 weeks of each 12-week phase)
  Number of catheter changes (for any reason: CAUTI, blockage, dislodgement, or other) per participant during the first 4 weeks of each 12-week catheter phase, normalized to per 100 catheter days. Compared between catheter types using within-participant paired analysis.
• Incidence of catheter changes per 100 catheter days over the full 12-week treatment phase — Weeks 0-12 and weeks 12-24 (full 12 weeks of each phase)
  Number of catheter changes per participant during the full 12-week phase, normalized to per 100 catheter days. Compared between catheter types using within-participant paired analysis.

Trial sites (3)