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.
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
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
Crossover
NowCath Foley
DeviceAll-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.
Conventional All-Silicone Foley Catheter
DeviceCE-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.
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.
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.
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).
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 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.
Bacterial species identified in CAUTI episodes
Identification of causative uropathogens in urine cultures from CAUTI episodes.
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.
Click on the lead sponsor to view all of their trials.
Nowwell AS
Lead sponsor
Holstebro Municipality
Collaborator
Ikast-Brande Municipality
Collaborator
University of Aarhus
Collaborator
Gødstrup Hospital
Collaborator
