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

NCT07782762 | Recruiting DMC

• 1 other identifier: 2026051430
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Urinary Catheter; Indwelling catheter; CAUTI; catheter associated urinary tract infection; catheter encrustation; foley catheter; catheter blockage; community nursing; crossover trial; silicone urinary catheter; medical device; urology; long-term indwelling catheterization

Outcome Measures

Primary Outcomes (2)

• Incidence of catheter changes per 100 catheter days during the first 4 weeks of each treatment 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.

  Weeks 0-4 and weeks 12-16 (first 4 weeks of each 12-week phase)

• Incidence of catheter changes per 100 catheter days over the full 12-week treatment 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.

  Weeks 0-12 and weeks 12-24 (full 12 weeks of each phase)

Secondary Outcomes (11)

• Catheter-related quality of life (ICIQ-LTCqol)

  Weeks 0, 12, and 24

• General health-related quality of life (EQ-5D-5L)

  Weeks 0, 12, and 24

• Residual urine volume

  Weeks 12 and 24

• Time to first asymptomatic bacteriuria

  Weeks 0-24

• Incidence of catheter-associated urinary tract infection (CAUTI) per 100 catheter days

  Weeks 0-12 and weeks 12-24

Other Outcomes (2)

• Bacterial species identified in CAUTI episodes

  Weeks 0-24

• Blinding integrity

  Week 24

Study Arms (2)

Sequence A: NowCath Foley → Conventional Foley

EXPERIMENTAL

Participants receive the NowCath Foley catheter during weeks 0-12, followed by a scheduled catheter change to the conventional all-silicone Foley catheter for weeks 12-24.

Device: NowCath Foley; Device: Conventional All-Silicone Foley Catheter

Sequence B: Conventional Foley → NowCath Foley

EXPERIMENTAL

Participants receive the conventional all-silicone Foley catheter during weeks 0-12, followed by a scheduled catheter change to the NowCath Foley catheter for weeks 12-24.

Device: NowCath Foley; Device: Conventional All-Silicone Foley Catheter

Interventions

NowCath Foley DEVICE

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.

Sequence A: NowCath Foley → Conventional Foley; Sequence B: Conventional Foley → NowCath Foley

Conventional All-Silicone Foley Catheter DEVICE

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.

Sequence A: NowCath Foley → Conventional Foley; Sequence B: Conventional Foley → NowCath Foley

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nowwell AS: lead
• Holstebro Municipality: collaborator
• Ikast-Brande Municipality: collaborator
• University of Aarhus: collaborator
• Gødstrup Hospital: collaborator

Study Sites (3)

Gødstrup Hospital, Department of Medicine

Herning, 7400, Denmark

RECRUITING

Holstebro Municipality

Holstebro, 7500, Denmark

RECRUITING

Ikast-Brande Municipality

Ikast, 7430, Denmark

RECRUITING

Related Publications (5)

• ASTM F623 Standard performance specification for Foley catheter.

  BACKGROUND

• ISO 20696 Sterile urethral catheters for single use.

  BACKGROUND

• ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice.

  BACKGROUND

• Regulation (EU) 2017/745 on medical devices (MDR).

  BACKGROUND

• Wilde MH, McMahon JM, Fairbanks E, et al. Feasibility of a web-based self-management intervention for intermittent urinary catheter users. Res Nurs Health. 2017;40(6):533-543.

  BACKGROUND

MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Frank Holden Mose, MD, PhD

  Gødstrup Hospital, Department of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikolai Hoffmann-Petersen, MD, PhD, MBA Sponsor representative/Chief Executive Officer

CONTACT

+45 29464510; nhp@nowwell.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, treating physicians, and community-nursing personnel are blinded to catheter allocation through identical over-labelling of both catheter types. Study coordinators and the Principal Investigator are unblinded for safety monitoring and logistical oversight. Blinding integrity is assessed at week 24 with a participant questionnaire.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each participant receives both catheters in a randomly assigned order (NowCath Foley then comparator, or comparator then NowCath Foley), with each treatment phase lasting 12 weeks. There is no washout period; the crossover occurs at a scheduled catheter change at week 12.

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 24, 2026
• Study Start: August 10, 2026
• Primary Completion (Estimated): August 10, 2027
• Study Completion (Estimated): December 10, 2027
• Last Updated: August 24, 2026

Record last verified: 2026-08

Locations

DK (3)