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

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.

Conditions

• Urinary Catheters
• Urinary Catheterization
• Catheter-Related Infections
• Catheter Associated Urinary Tract Infection

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• Holstebro Municipality

  collaborator UNKNOWN

• Ikast-Brande Municipality

  collaborator UNKNOWN

• University of Aarhus

  collaborator OTHER

• Gødstrup Hospital

  collaborator OTHER

• Nowwell AS

  lead INDUSTRY

Principal Investigators

• Frank Holden Mose, MD, PhD · Gødstrup Hospital, Department of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-10

Primary Completion

2027-08-10

Completion

2027-12-10

Countries

• Denmark

Study Locations