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

RecruitingNAAges 18 Years - anyAllNowwell AS
NCT07782762 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 p

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📋 Eligibility rules (as published)
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
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What it tests

  • NowCath Foley
  • Conventional All-Silicone Foley Catheter
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Where

3 sites
Gødstrup Hospital, Department of Medicine
Herning, Denmark
Holstebro Municipality
Holstebro, Denmark
Ikast-Brande Municipality
Ikast, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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