An Observational, Multinational, In Hospital Evaluation of Catheter Utilization Rates in Female Patients Using Indwelling Urinary Catheters and the PureWick™ Flex Female External Catheter Across Europe and the Middle East

N/ANot Yet RecruitingNCT07798128

Becton, Dickinson and Company240 enrolled

Overview

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.

Interventions

PureWick™ Flex Female External Catheter (FFEC)DEVICE

A 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)DEVICE

An 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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult female subjects ≥ 18 years of age at the time of signing the informed consent. 2. 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. 3. Has limited mobility and is not able to use sanitary devices that facilitate controlled bladder emptying like bedpans, commode chairs, voiding at the toilet 4. The expected length of stay from enrollment to hospital discharge is at minimum 10 days 5. Willing to comply with all study procedures in this protocol 6. The subject must be willing and able to read, understand, sign, and date the informed consent form. Exclusion Criteria: 1. Clinically confirmed urinary retention. 2. Requiring precise urine output measurement 3. Is known to be pregnant at time of enrollment 4. 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 5. Has documented colonization or infection with multidrug-resistant organisms (MDROs) at the time of the planned indwelling urinary catheter implantation 6. Is agitated, combative, and/or uncooperative and may remove the catheter 7. Has any pre-existing neurological, psychiatric, or other conditions that would confound quality of life assessment or would make it difficult to self-report on quality-of-life questionnaires in the opinion of the investigator 8. Has any other condition that, in the opinion of the investigator, would preclude them from participating in the study. Additional Exclusion Criteria (Cohort 2 only - PureWick™ FFEC): 9. Has frequent episodes of bowel incontinence without a fecal management system in place 10. Has moderate to heavy menstruation and cannot use a tampon or menstrual cup 11. Has vaginal or other chronic non-urinary tract infections (UTIs), active genital herpes 12. Has any clinically relevant skin condition (e.g. wound, lesion or irritation) affecting the genital, perineal, or sacral area that could interfere with safe and effective device use where is in contact with the device.

Outcomes

Primary Outcomes

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.

Time frame: From enrollment (informed consent) until hospital discharge or up to 40 days, whichever occurs first

Secondary Outcomes

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.

Time frame: From enrollment until hospital discharge or up to 40 days

Length of Hospital Stay (LOS)

Number of days from study enrollment (informed consent) to hospital discharge or end of study.

Time frame: From enrollment until discharge or up to 40 days