Urinary catheterization is commonly used in hospitalized patients for the management of urinary incontinence, immobilization, and monitoring of urinary output. However, indwelling urinary catheters (IUCs) are associated with clinically significant risks, including catheter-associated urinary tract infections (CAUTIs), other infectious and non-infectious complications, prolonged hospital stay, and increased healthcare costs. The risk of complications increases with the duration of catheterization, highlighting the need for strategies to reduce unnecessary catheter use and minimize catheter dwell time.
The PureWick™ Female External Catheter (FFEC) is a non-invasive urine collection device designed to manage urinary incontinence in female patients without the need for an indwelling catheter. By providing an alternative approach to urinary management, it has the potential to reduce reliance on IUCs and associated complications while improving patient comfort and quality of care.
This study is a prospective, multinational, observational, sequential two-cohort study conducted in hospitalized adult female patients across Europe and the Middle East. The study aims to evaluate the effect of introducing the PureWick™ FFEC into clinical practice on indwelling urinary catheter utilization rates in routine hospital care.
Approximately 240 adult female patients requiring urinary management for incontinence during hospitalization will be enrolled across multiple clinical sites. The study consists of two sequential cohorts within participating sites. In Cohort 1, patients will receive standard care using indwelling urinary catheters only. In Cohort 2, following the introduction of the PureWick™ FFEC, patients will be managed using either the external catheter alone or in combination with indwelling catheters, according to routine clinical practice.
The primary objective is to compare indwelling urinary catheter utilization rates before and after the introduction of the PureWick™ FFEC. Catheter utilization is defined as the proportion of inpatient days during which an indwelling catheter is used (catheter-days per patient-days).
Secondary objectives include assessment of the occurrence and nature of adverse events, including urinary tract infections, catheter-associated urinary tract infections, incontinence-associated dermatitis, and falls, as well as evaluation of hospital length of stay. Exploratory objectives include assessment of patient and healthcare professional experience, device usability and satisfaction, pain and discomfort, and sleep quality.
Participants will be followed from enrollment until hospital discharge or up to 40 days, whichever occurs first. The results of this study are intended to provide real-world evidence on urinary catheter utilization patterns and to inform clinical practice regarding the role of non-invasive urinary management strategies in hospitalized female patients.
Adult female subjects ≥ 18 years of age at the time of signing the informed consent.
Requiring treatment with indwelling urinary catheters or PureWick™ Flex Female External Catheter (PureWick™ FFEC) for urinary management, including urinary incontinence for at least 3 days after enrollment.
Has limited mobility and is not able to use sanitary devices that facilitate controlled bladder emptying like bedpans, commode chairs, voiding at the toilet
The expected length of stay from enrollment to hospital discharge is at minimum 10 days
Clinically confirmed urinary retention.
Requiring precise urine output measurement
Is known to be pregnant at time of enrollment
Has a confirmed diagnosis of a urinary tract infection (UTI), catheter-associated urinary tract infection (CAUTI), or sepsis at the time of the planned indwelling urinary catheter implantation
Hospitalized adult female patients (≥18 years) requiring urinary management for incontinence and who are unable to use standard toileting methods due to limited mobility. Participants are expected to have an inpatient stay of at least 10 days and require use of a urinary collection approach, including indwelling urinary catheters and/or a non-invasive external urinary catheter system, as part of routine clinical care. Subjects will be enrolled from acute care hospital settings across multiple sites in Europe and the Middle East, representing a real-world inpatient population requiring urinary management.
Cohort
Prospective
PureWick™ Flex Female External Catheter (FFEC)
DeviceA non-invasive external urine collection device used for management of urinary incontinence in hospitalized female patients. The device is applied externally and connected to low-pressure suction for urine collection. It is used according to routine clinical practice, either as first-line management or following use of an indwelling urinary catheter.
Indwelling Urinary Catheter (IUC)
DeviceAn internal urinary catheter inserted into the bladder to allow continuous drainage of urine, used as part of standard of care in hospitalized patients. Type and model may vary according to institutional practice.
Indwelling Urinary Catheter (IUC) Utilization Rate
The proportion of inpatient days during which an indwelling urinary catheter is used, defined as the number of catheter-days divided by the total number of patient-days.
Occurrence of Adverse Events (AEs)
Incidence and nature of adverse events, including all adverse events, device- and/or procedure-related events, and serious adverse events. Events of interest include catheter-associated urinary tract infections (CAUTI), urinary tract infections (UTI), incontinence-associated dermatitis (IAD), and falls.
Length of Hospital Stay (LOS)
Number of days from study enrollment (informed consent) to hospital discharge or end of study.
Patient and Healthcare Professional (HCP) Assessment of Device Use
Assessment of usability, comfort, satisfaction, and preference for urinary management methods, collected using structured questionnaires at the end of the treatment period.
Pain Associated with Urinary Management
Patient-reported pain assessed using standardized scales, including Numeric Pain Rating Scale (NRS).
Sleep Disturbance
Patient-reported sleep disturbance assessed using the PROMIS Sleep Disturbance questionnaire.
Discomfort Associated with Urinary Management
Patient-reported discomfort associated with urinary management, including Catheter-Related Bladder Discomfort (CRBD), assessed using study-specific questionnaires and standardized assessment tools.
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