An interventional study of NowCath Foley and Conventional All-Silicone Foley Catheter in Urinary Catheters, Urinary Catheterization and Catheter-Related Infections, sponsored by Nowwell AS. Recruiting at 3 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Nowwell AS · Not applicable, Interventional, and Treatment
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.
Background Adults who depend on long-term indwelling urethral or suprapubic Foley catheters in the community setting frequently experience catheter-associated urinary tract infections (CAUTIs), catheter blockages, and unscheduled catheter changes. These complications are associated with increased antibiotic exposure, hospital and emergency visits, morbidity, and impaired quality of life. Antimicrobial coatings and other design modifications tested to date have shown limited long-term benefit. Two of the pathophysiological drivers of these complications are incomplete bladder emptying, which leaves a residual reservoir that supports bacterial growth and crystalline precipitation, and mucosal contact with the drainage eyelets, which can cause local trauma and inflammation.
Investigational Device
The NowCath Foley is an all-silicone indwelling urinary catheter conforming to ISO 20696 and ASTM F623. It differs from a conventional all-silicone Foley catheter in two respects: two additional drainage eyelets positioned below the retention balloon, and a thin flexible silicone skirt that covers these eyelets to reduce mucosal suction. The device is intended for long-term (up to 90 days) indwelling urethral or suprapubic use.
Comparator A commercially available, CE-marked all-silicone Foley catheter (Rüsch Brillant, Teleflex Medical) representing the current standard of care.
Regulatory Framework The study is a pre-market pivotal clinical investigation conducted under Regulation (EU) 2017/745 (MDR) in accordance with ISO 14155:2020 and the Declaration of Helsinki. A clinical evaluation concluded that additional clinical data are required to confirm compliance with the relevant General Safety and Performance Requirements.
Primary Hypothesis The NowCath Foley reduces the incidence of catheter changes per 100 catheter days compared with a conventional all-silicone Foley catheter in long-term indwelling catheter users.
Objectives Primary: To compare the incidence of catheter changes per 100 catheter days during the first 4 weeks of each 12-week treatment phase between the NowCath Foley and the comparator catheter.
Co-primary: To compare the incidence of catheter changes per 100 catheter days over the full 12-week phase between the two catheters.
Secondary: To compare CAUTI incidence, blockage requiring catheter removal, residual urine volume, time to first asymptomatic bacteriuria, catheter encrustation severity, antibiotic use, catheter-related quality of life (ICIQ-LTCqol), general health-related quality of life (EQ-5D-5L), patient comfort and satisfaction, study-coordinator-reported ease of insertion, participant preference, and within-trial cost-effectiveness.
Safety: To monitor adverse events, adverse device effects, serious adverse events, serious adverse device effects, and catheter-related complications (including urethral trauma, bladder trauma, haematuria, allergic and skin reactions), classified per ISO 14155:2020.
Study Design Multi-centre, prospective, randomized, blinded, controlled crossover clinical investigation. Each participant undergoes two consecutive 12-week treatment phases in a randomly assigned sequence (NowCath Foley then comparator, or comparator then NowCath Foley), allocated 1:1. There is no washout between phases; the crossover coincides with a scheduled catheter change. Patients, treating physicians, and community-nursing personnel are blinded to catheter allocation through use of identical over-labelling; study coordinators and the principal investigator are unblinded for safety and logistical oversight.
Population Adults (≥18 years) receiving community nursing care from Ikast-Brande or Holstebro municipalities in Denmark, with an indwelling urethral or suprapubic Foley catheter in place for ≥28 days at enrolment and an expected need for continued catheterization for at least 6 months.
Sample Size A total of 160 participants will be enrolled. The sample size was determined by simulation to provide 90% power at a two-sided 5% significance level to detect the assumed between-catheter difference on the primary endpoint. Assumptions: a background incidence of 1.536 catheter changes per 100 catheter days for the conventional catheter (Wilde MH et al., Res Nurs Health 2017), a 60% reduction in CAUTI- and blockage-related changes with the NowCath Foley (dislodgement rate unchanged), and 25% withdrawal over 24 weeks. The paired between-catheter comparison uses a Wilcoxon signed-rank test. Simulation indicated 148 evaluable participants; 160 will be enrolled to accommodate first-phase dropouts.
Statistical Analysis The intention-to-treat population, comprising all randomized participants analysed according to assigned sequence, is the primary analysis population. Primary endpoints are analysed using the Wilcoxon signed-rank test on within-participant paired differences in catheter-change rates. Multiplicity across the two co-primary endpoints will be controlled through a pre-specified hierarchical testing strategy defined in the statistical analysis plan. Secondary endpoints are pre-specified but not formally powered.
Study Duration Each participant is followed for 24 weeks (two 12-week phases) plus screening and close-out. Clinic visits occur at week 0 (baseline), week 12 (crossover catheter change), and week 24 (end of study). Weekly urine sampling (at home or on site) is performed at weeks 1-11 and 13-23. Additional telephone contact occurs as clinically indicated.
Sites Community nursing services of Ikast-Brande and Holstebro municipalities, in collaboration with the Department of Medicine, Regional Hospital Gødstrup, Denmark.
112 studies on the registry are indexed under Catheter-Related Infections; 18 are open to participants now.
This study's planned enrollment of 160 is close to the median of 149 across 84 interventional studies indexed under Catheter-Related Infections.
Browse Catheter-Related Infections studies →This is the only study on the registry with Nowwell AS as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: 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.
Time frame: Weeks 0-12 and weeks 12-24 (full 12 weeks of each phase)
Catheter-related quality of life (ICIQ-LTCqol)
International Consultation on Incontinence Questionnaire - Long-Term Catheter quality of life score. Higher scores indicate greater catheter-related impact on quality of life. 17 item questionnaire. Scores: 0-42 Catheter function and concern; 3-15 Lifestyle impact.
Time frame: Weeks 0, 12, and 24
General health-related quality of life (EQ-5D-5L)
EQ-5D-5L descriptive system and visual analogue scale. Captures health status in five key dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension uses a 5-level Likert scale (1 = no problems, 5 = extreme problems) EQ-5D-5L offers two primary scoring methods: Level Sum Score (LSS): Sum the scores from each dimension (1-5), yielding a total of 5-25. Higher scores indicate worse health status. Utility Score: Derived from country-specific value sets, these scores reflect societal preferences for health states, often used in economic evaluations. VAS Score: A 0-100 scale where patients rate their overall health (0= worst imaginable health and 100 = best imaginable health).
Time frame: Weeks 0, 12, and 24
Residual urine volume
Post-drainage residual bladder volume measured by portable bladder scan, in millilitres. Lower values indicate more effective bladder emptying, measured consecutively 3 times to generate mean value.
Time frame: Weeks 12 and 24
Time to first asymptomatic bacteriuria
Time from start of each catheter phase to first urine sample meeting criteria for asymptomatic bacteriuria, based on weekly urine sampling.
Time frame: Weeks 0-24
Incidence of catheter-associated urinary tract infection (CAUTI) per 100 catheter days
Number of CAUTI episodes per 100 catheter days within each catheter phase, per pre-specified diagnostic criteria.
Time frame: Weeks 0-12 and weeks 12-24
Incidence of catheter blockage requiring catheter removal per 100 catheter days
Number of catheter blockage events leading to catheter change per 100 catheter days within each phase.
Time frame: Weeks 0-12 and weeks 12-24
Catheter encrustation severity
Visual encrustation score on a 0-12 scale (higher = greater encrustation), assessed on all removed catheters. Proportion of catheters with severe encrustation (grade ≥3) also reported. Photographic documentation retained.
Time frame: At each catheter removal (weeks 12, 24, and unscheduled removals)
Antibiotic use
Type, frequency, and duration of systemic antibiotic use for any indication, and separately for use consistent with CAUTI treatment guidelines.
Time frame: Weeks 0-24
Within-trial cost-effectiveness
Incremental cost-effectiveness ratio (ICER) per catheter change prevented, calculated within the trial time horizon from a healthcare-system perspective.
Time frame: Weeks 0-24
Study-coordinator-reported ease of catheter insertion
Ease-of-insertion score on a 10-point scale (1 = very difficult; 10 = very easy), rated by the inserting study coordinator. Scores are combined with questions regarding the subjective experience of the device with the options for device users to express whether included parameters positively or negatively affected their experience.
Time frame: At each catheter insertion (weeks 0, 12, and unscheduled)
Participant preference between catheters
Participant-reported preference between the two catheters at end of study.
Time frame: Week 24
Bacterial species identified in CAUTI episodes
Identification of causative uropathogens in urine cultures from CAUTI episodes.
Time frame: Weeks 0-24
Blinding integrity
Participant-completed blinding questionnaire assessing perceived catheter allocation, used to evaluate integrity of masking. Bang's blinding index is calculated per treatment arm and assesses whether or not patients can correctly guess which treatment arm (Teleflex or NowCath) subjects were assigned at randomization for phase 1 and phase 2 of the study. If the index is 1, all responses are correct, and complete unblinding is inferred. If the index is -1, all responses are incorrect, and complete blinding is inferred, albeit, this may indicate unblinding in the opposite direction (e.g. opposite guessing). If the index is 0, then half of the guesses are correct and half of the guesses are incorrect, inferring random guessing.
Time frame: Week 24
Plan to share: No — There is no requirement to publish Individual participant data (IDP) for this study. IDP will not be shared due to privacy regulations, the participant consent process is developed accordingly. The study protocol and data sharing agreements do not include provisions for releasing de-identified individual data to external researchers.
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