An observational study in Urinary Incontinence and Limited Mobility, sponsored by Becton, Dickinson and Company. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Becton, Dickinson and Company · Observational
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.
983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.
This study's planned enrollment of 240 is above the median of 120 across 215 observational studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Becton, Dickinson and Company is the lead sponsor of 61 studies on the registry; 5 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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:
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):
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants managed for urinary incontinence using indwelling urinary catheters only, in accordance with routine clinical practice.
Device: Indwelling Urinary Catheter (IUC)
Participants managed for urinary incontinence following the introduction of the PureWick™ Female External Catheter, using either the external catheter alone or in combination with indwelling urinary catheters, in accordance with routine clinical practice.
Device: PureWick™ Flex Female External Catheter (FFEC) · Device: Indwelling Urinary Catheter (IUC)
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.
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.
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
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
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.
Time frame: Patient assessments are collected at baseline, every 7 days during device use, and at device removal/discharge. HCP assessments are collected at device removal, hospital discharge, or Day 40/end of study.
Pain Associated with Urinary Management
Patient-reported pain assessed using standardized scales, including Numeric Pain Rating Scale (NRS).
Time frame: Baseline through discharge or Day 40.
Sleep Disturbance
Patient-reported sleep disturbance assessed using the PROMIS Sleep Disturbance questionnaire.
Time frame: Assessed at baseline, Day 7, Day 14, Day 28, and at hospital discharge or Day 40, whichever occurs first.
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.
Time frame: Assessed at baseline, every 7 days (±1 day) during device use, and at device removal, hospital discharge, or Day 40, whichever occurs first.
No study locations are listed for this record.
Plan to share: No — No. Individual participant data (IPD) will not be shared. The study protocol does not include provisions for external sharing of participant-level data. Subject data will be pseudonymized and handled in accordance with applicable privacy regulations, including GDPR, and study results will be reported in aggregate form
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jun 2027, 7 months later.
Of 74 observational studies under Urinary Incontinence, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 50. This study's planned 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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