NowCath Foley: a new catheter to lower bladder infections and blockages for long-term users

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The REDUCE study is a multi-center, randomized, blinded, controlled crossover trial conducted in Denmark to compare the NowCath Foley against a standard all-silicone catheter. The device features two additional drainage eyelets and a silicone skirt designed to minimize mucosal suction and improve bladder emptying. Participants are adults with an indwelling catheter for at least 28 days and a plan for continued use beyond 6 months, monitored over a 12-month period. The primary goal is to determine whether the NowCath catheter lowers the incidence of CAUTI compared with the conventional catheter. This pivotal investigation follows ISO 20696 and ASTM F623 guidelines and involves community nursing settings with collaboration from university and municipal partners.

Why it matters

Who can join: the full rules

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

Where it's running

• Gødstrup Hospital, Department of Medicine
  Herning, Denmark Recruiting
• Holstebro Municipality
  Holstebro, Denmark Recruiting
• Ikast-Brande Municipality
  Ikast, Denmark Recruiting

Study contacts

• Principal investigator: Frank Holden Mose, MD, PhD — Gødstrup Hospital, Department of Medicine
• Study coordinator: Nikolai Hoffmann-Petersen, MD, PhD, MBA Sponsor representative/Chief Executive Officer
• Email: nhp@nowwell.com
• Phone: +45 29464510

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.