REDUCE Trial

STATUS
Recruiting
01 Purpose01 — 07

Investigating a persistent challenge

People using long-term indwelling urinary catheters often experience urinary tract infections, blockages and unscheduled catheter changes.

REDUCE is investigating whether NowCath Foley can reduce the rate of catheter changes compared with a conventional all-silicone Foley catheter.

Catheter changes

Scheduled and unscheduled

01

Blockage

Requiring catheter removal

02

CAUTI

Catheter-associated urinary tract infection

03
02 Investigational device02 — 07

A different approach to urinary drainage

NowCath Foley is an all-silicone indwelling urinary catheter with two additional drainage eyelets positioned below the balloon. The design is intended to safely and effectively improve bladder emptying.

03 Study overview03 — 07

Designed to compare

REDUCE is a multicentre, prospective, randomised, blinded, controlled crossover clinical investigation. Each participant uses both catheters in a randomly assigned order.

160Participants
24 weeksStudy participation
2 × 12One period with each catheter
2Recruiting locations in Denmark
04 Study design04 — 07

Every participant. Both catheters.

Participants are randomly assigned to one of two study sequences.

Sequence A
Weeks 0–12

NowCath Foley

Week 12Scheduled catheter change
Weeks 12–24

Conventional Foley

Sequence B
Weeks 0–12

Conventional Foley

Week 12Scheduled catheter change
Weeks 12–24

NowCath Foley

05 Primary outcomes05 — 07

Measuring catheter changes

The primary comparison is the incidence of catheter changes per 100 catheter days.

4 weeks

Catheter changes during the first 4-weeks of the study period.

CO-Primary endpoint
12 weeks

Catheter changes during the full 12-weeks the study period.

co-primary endpoint
06 Secondary outcomes06 — 07

Looking beyond catheter changes

The investigation also evaluates clinical outcomes, catheter condition, participant experience and care delivery.

Clinical outcomes

CAUTI, blockage requiring catheter removal, residual urine and time to asymptomatic bacteriuria.

01

Catheter condition

The presence and severity of catheter encrustation.

02

Participant experience

Catheter-related and general quality of life, comfort, satisfaction and catheter preference.

03

Care delivery

Ease of insertion, antibiotic use, safety, catheter-related complications and within-trial cost-effectiveness.

04
07 Collaboration and status07 — 07

A multicentre investigation in Denmark

The REDUCE Trial is sponsored by Nowwell Flow Technology AS and conducted with clinical and municipal partners.

Ikast-Brande Municipality
Holstebro Municipality
Gødstrup Hospital
Aarhus University Hospital
Aarhus University

Frank Holden Mose, MD, PhD

Gødstrup Hospital, Department of Medicine

Principal Investigator
Partners

Currently recruiting in Denmark

Visit ClinicalTrials.gov for information about recruitment, eligibility, locations and study status.

NCT07782762

No study results have been posted. NowCath Foley is being evaluated as an investigational device in the REDUCE Trial.